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Siemens Healthcare Diagnostics, Inc. FDA Recalls

173 recalls on file across devices, 0 of them Class I and 163 still open. This firm is not matched to a listed company.

Newest first

Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Product
Syva EMIT 2000 Quinidine Assay REF: 4Q019UL Contents: 1x28 mL, 1x14mLClass IIJul 13, 2026Due to unacceptable precision performance exhibited in certa
Beckman Coulter, Emit 2000 Quinidine Assay REF: OSR4Q229 Contents: R1: 2 x 23 mL;R2 2x13 mLClass IIJul 13, 2026Due to unacceptable precision performance exhibited in certa
Atellica CH Urine Albumin REF: 11537225, in vitro diagnosticClass IIJul 6, 2026Processing of urine albumin assay on the CI analyzers may le
Syva Emit Disopyramide Assay Enzyme Immunoassay, Lidocaine SMN 10445370 Catalog No 6N319ULClass IIIJun 26, 2026Out-of-specification sodium azide concentration in Syva Emit
Syva Emit tox Serum Tricyclic Antidepressant Calibrator/Controls SMN 10445390 Catalog No. 7C219ULClass IIIJun 26, 2026out-of-specification sodium azide concentration in Syva Emit
Atellica CH Enzymatic Hemoglobin A1c (A1c_E). Material Number: 11097536.Class IIJun 8, 2026The potential for intermittent well-to-well bias on the A1c_
Siemens Dimension Tacrolimus Flex Reagent Cartridge (TAC), REF DF207, SMN 10700795; enzyme immunoassayClass IIMay 7, 2026A potential positive bias in quality control (QC) and patien
epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System; Siemens Material Number (SMN): 10736515;Class IIApr 2, 2026Use of the affected product can result in discrepant low pH
Dimension Creatinine Flex reagent cartridge. Material Number: 10872079.Class IIMar 18, 2026Siemens Healthcare Diagnostics is recalling certain lots of
Atellica CH Enzymatic Hemoglobin A1c (A1c_E); Siemens Material Number (SMN): 11097536;Class IIFeb 23, 2026A potential for depressed results for Atellica CH A1c_E when
Atellica CH Urine Albumin (UAlb). Material Number: 11537225Class IIJan 20, 2026Falsely depressed UAlb patient results may occur. Affected
Food Panel 3 Specific Allergen; Siemens Material Number (SMN): 10385891; Catalog Number: FP3L4;Class IIOct 6, 2025The barcode orientation on affected devices causes incorrect
IMMULITE 2000 Oak Mix Specific Allergen; Siemens Material Number (SMN): 10386105; Catalog Number: L2KUN6;Class IIOct 6, 2025The barcode orientation on affected devices causes incorrect
3gAllergy Specific IgE Universal Kit; Kit Component: 3gAllergy Specific IgE Adjustor Antibody (L2UNS1), 3gAllergy SpeciClass IIOct 6, 2025The barcode orientation on affected devices causes incorrect
Assay: IMMULITE 2000 Intact PTH; Test Code: iPT; Siemens Material Number (SMN): (1) 10381441, (2) 10381442; Catalog NClass IISep 22, 2025The potential for falsely depressed Intact PTH patient resul
Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP). Material Number: 11097543.Class IIAug 11, 2025Potential for falsely depressed patient, quality control (QC
epoc BGEM BUN Test Card [25pk]. Material Number: 10736515.Class IIJul 7, 2025Siemens Healthcare Diagnostics Inc. has confirmed that a neg
RAPIDPoint 500 Systems Wash/Waste Cartridge (4 Pack). Material Number: 10329097.Class IIJun 26, 2025Siemens Healthcare Diagnostics is recalling the RAPIDPoint 5
ADVIA¿ 120/2120/2120i 3-in-1 TESTpoint Control (ABN1 Control)Class IIJun 4, 2025Products have the incorrect platelet (PLT) value assignments
ADVIA¿ 120/2120/2120i 3-in-1 TESTpoint Control (Norm Control)Class IIJun 4, 2025Products have the incorrect platelet (PLT) value assignments
ADVIA¿ 120/2120/2120i 3-in-1 TESTpoint Control (ABN2 Control)Class IIJun 4, 2025Products have the incorrect platelet (PLT) value assignments
ADVIA¿ 120/2120/2120i SETpoint CalibratorClass IIJun 4, 2025Products have the incorrect platelet (PLT) value assignments
Product: Atellica CH Diluent - CONS 2 x 1.5L; Siemens Material Number (SMN): 11099300;Class IIMay 22, 2025Contamination of the diluent by sodium hypochlorite (NaOCl)
Atellica IM Homocysteine Calibrator (2 Pack). Siemens Material Number: 10995498Class IIApr 15, 2025Certain lots of Atellica IM Homocysteine Calibrator and ADVI
ADVIA Centaur HCY Calibrator (2 Pack). Siemens Material Number: 10310376.Class IIApr 15, 2025Certain lots of Atellica IM Homocysteine Calibrator and ADVI
Stratus CS Acute Care cTNI TestPak.IVD test for cardiac troponin I in heparinized plasma.Class IIMar 31, 2025Siemens Healthcare Diagnostics Inc., is recalling their Stra
epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System; Siemens Material Number (SMN): 10736515; epoc SoftwaClass IIMar 19, 2025The occurrence of discrepant high pH results in samples intr
epoc BGEM Crea Test Card (25 pk) for the epoc Blood Analysis System; Siemens Material Number (SMN): 10736382; epoc SoftwClass IIMar 19, 2025The occurrence of discrepant high pH results in samples intr
Atellica CH Revised C Reactive Protein (RCRP); Siemens Material Number (SMN): 11537223.Class IIMar 11, 2025Incorrect software flagging may occur for the assay that may
epoc NXS Host; Siemens Material Number (SMN): 11413475 (US); Software Version Number: 4.14.9. Intended for use by trainClass IINov 22, 2024Siemens Healthcare Diagnostics is recalling their epoc Blood
epoc NXS Host; Siemens Material Number (SMN): 11413517(MX) ; Software Version Number: 4.14.9. Intended for use by traClass IINov 22, 2024Siemens Healthcare Diagnostics is recalling their epoc Blood
epoc NXS Host; Siemens Material Number (SMN): 11413879(IN) ; Software Version Number: 4.14.9. Intended for use by traClass IINov 22, 2024Siemens Healthcare Diagnostics is recalling their epoc Blood
epoc NXS Host; Siemens Material Number (SMN): 11413518 (ROW) ; Software Version Number: 4.14.9. Intended for use by tClass IINov 22, 2024Siemens Healthcare Diagnostics is recalling their epoc Blood
epoc NXS Host; Siemens Material Number (SMN): 11413497 (EU); Software Version Number: 4.14.9. Intended for use by traClass IINov 22, 2024Siemens Healthcare Diagnostics is recalling their epoc Blood
epoc NXS Host; Siemens Material Number (SMN): 11413506 (CA); Software Version Number: 4.14.9. Intended for use by traClass IINov 22, 2024Siemens Healthcare Diagnostics is recalling their epoc Blood
epoc NXS Host; Siemens Material Number (SMN): 11413583(CN, KR) ; Software Version Number: 4.14.9. Intended for use byClass IINov 22, 2024Siemens Healthcare Diagnostics is recalling their epoc Blood
epoc NXS Host; Siemens Material Number (SMN): 11413498(JP) ; Software Version Number: 4.14.9. Intended for use by traClass IINov 22, 2024Siemens Healthcare Diagnostics is recalling their epoc Blood
Magnesium Flex reagent cartridge, 360 tests, Catalog Number: K3057; Siemens Material Number (SMN): 10445158;Class IINov 12, 2024Siemens Healthcare Diagnostics is recalling two lots of thei
Atellica CI Analyzer. Catalog Numbers: 10947347.Class IINov 4, 2024Potential that the IMT Diluent volume remaining (% remaining
Siemens Atellica CH Reaction Ring Cuvette Segment-has cuvettes that contain and incubate the sample reaction volumes andClass IIOct 21, 2024A manufacturing defect causes Atellica CH Reaction Ring Cuve
Atellica¿ CH ¿2-Microglobulin (B2M) - In vitro diagnostic use in the quantitative determination of ¿2-microglobulin in hClass IIOct 21, 2024Potential for falsely depressed auto-diluted results for sa
IMMULITE 2000 PSA assay, Catalog Number L2KPTS2(D) (SMN 10706281) and Catalog Number L2KPTS6(D) (SMN 10706282)Class IISep 30, 2024The IMMULITE 2000 PSA assay for use on the IMMULITE 2000 and
epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System, SMN 10736515Class IISep 24, 2024Siemens Healthcare Diagnostics Inc. has confirmed that a neg
Atellica IM aTPO Assay, Material Number 10995466 (100 Test) and 10995467 (500 Test)Class IIAug 21, 2024Positive bias in patient results at and below the cut-off of
ADVIA Centaur aTPO Assay, Material Number 10630886 (100 Test) and 10630887 (500 Test)Class IIAug 21, 2024Positive bias in patient results at and below the cut-off of
ADVIA Chemistry Microalbumin_2 (¿ALB_2) -For in vitro diagnostic use in the quantitative measurement of microalbumin in Class IIAug 15, 2024Atellica CH Microalbumin_2 (¿ALB_2) and the ADVIA Chemistry
Atellica CH Microalbumin_2 (¿ALB_2)-For in vitro diagnostic use in the quantitative measurement of microalbumin in humanClass IIAug 15, 2024Atellica CH Microalbumin_2 (¿ALB_2) and the ADVIA Chemistry
Dimension Vista¿ Total Bilirubin (TBIL) Flex Reagent Cartridge; Siemens Material Number (SMN): 10445146;Class IIJul 30, 2024During manufacturing, the last three tests from the 160 test
ADVIA Chemistry Urinary/Cerebrospinal Fluid Protein (UCFP); Siemens Material Number (SMN): 11319151Class IIJul 29, 2024The potential for biased quality control (QC) and patient r
Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP); Siemens Material Number (SMN): 11097543Class IIJul 29, 2024The potential for biased quality control (QC) and patient r
Atellica IM CA 19-9 (50 Test)-In vitro diagnostic use in the quantitative measurement of the CA 19-9 tumor-associated anClass IIJul 26, 2024Positive bias for some samples around the CA 19-9 upper limi
Atellica IM CA 19-9 (250 Test)- In vitro diagnostic use in the quantitative measurement of the CA 19-9 tumor-associated Class IIJul 26, 2024Positive bias for some samples around the CA 19-9 upper limi
Atellica IM CA 19-9 (250 Test - REF)-In vitro diagnostic use in the quantitative measurement of the CA 19-9 tumor-associClass IIJul 26, 2024Positive bias for some samples around the CA 19-9 upper limi
ADVIA Centaur CA 19-9 (50 Test)-In vitro diagnostic use in the quantitative measurement of the CA 19-9 tumor-associated Class IIJul 26, 2024Positive bias for some samples around the CA 19-9 upper limi
ADVIA Centaur CA 19-9 (250 Test)-In vitro diagnostic use in the quantitative measurement of the CA 19-9 tumor-associatedClass IIJul 26, 2024Positive bias for some samples around the CA 19-9 upper limi
Software version 5.3 in: RAPIDPoint 500e Blood Gas System (USA) Siemens Material Number: 11416751 RAPIDPoint 500eClass IIMay 17, 2024Siemens Healthineers has identified an issue with the RAPIDP
IMMULITE 2000 Anti-TG Ab Catalog # L2KTG6 (600 Tests), SMN 10381655, System, Test, Thyroid Autoantibody.Class IIApr 23, 2024The potential for falsely elevated patient sample results wh
IMMULITE 2000 Anti-TG Ab Catalog # L2KTG2 (200 Tests), SMN 10381659, System, Test, Thyroid Autoantibody.Class IIApr 23, 2024The potential for falsely elevated patient sample results wh
Atellica CH Iron3 - IVD use in the quantitative measurement of iron in human serum and plasma (lithium heparin and sodiuClass IIMar 13, 2024Potential for falsely elevated Chol_2, LDLC, and Trig_2 resu
DCA Systems HbA1c Reagent KitClass IIFeb 7, 2024The reason for the recall is that the Siemens DCA HbA1c Reag
Atellica IM Erythropoietin (EPO) Assay (100 Test)Class IIJan 24, 2024Siemens Healthcare Diagnostics has confirmed an average nega
ADVIA Centaur Erythropoietin (EPO) Assay (100 Test)Class IIJan 24, 2024Siemens Healthcare Diagnostics has confirmed an average nega
Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetryClass IIDec 15, 2023Potential for a negative bias with quality control (QC) and
RAPIDPoint 500 Systems Measurement Cartridge (with Lactate) 250-Intended for in vitro diagnostic use and is designed to Class IIOct 26, 2023RAPIDPoint 500 Systems Measurement Cartridges (with lactate)
RAPIDPoint 500 Systems Measurement Cartridge (with Lactate) 100 -Intended for in vitro diagnostic use and is designed tClass IIOct 26, 2023RAPIDPoint 500 Systems Measurement Cartridges (with lactate)
RAPIDPoint 500 Systems Measurement Cartridge (with Lactate) 750-Intended for in vitro diagnostic use and is designed to Class IIOct 26, 2023RAPIDPoint 500 Systems Measurement Cartridges (with lactate)
RAPIDPoint 500 Systems Measurement Cartridge (with Lactate) 400-Intended for in vitro diagnostic use and is designed to Class IIOct 26, 2023RAPIDPoint 500 Systems Measurement Cartridges (with lactate)
epoc NXS Host Blood Analysis System, Siemens Material Numbers 11413497 (EU), 11413475 (US), 11413506 (CA), 11413517 (MX)Class IIOct 19, 2023Siemens Healthcare Diagnostics Inc. has confirmed a potentia
RAPIDPOINT 500 Blood Gas SystemClass IISep 26, 2023There are potential drug interferences from Perhexiline Male
RAPIDPOINT 500e Blood Gas SystemClass IISep 26, 2023There are potential drug interferences from Perhexiline Male
ADVIA Chemistry Iron_2 (IRON_2) Reagents, Material Numbers 10377510 (6 x 350 tests) and 10341118 (7 x 145 tests)Class IIAug 8, 2023There is a potential for a positive bias on Quality Control
ADVIA Chemistry Urinary/Cerebrospinal Fluid Protein (UCFP), Material Number 11319151, in vitro diagnostic use in the quClass IIJul 25, 2023There is a potential for ADVIA Chemistry Urinary/Cerebrospin
Atellica CH LDL Cholesterol- In vitro diagnostic use in the quantitative determination of LDL cholesterol in human seruClass IIJul 10, 2023Potential for reagent carryover on the Atellica CH 930 resul
Atellica CH Gamma-Glutamyl Transferase-IIn vitro diagnostic use in the quantitative determination of gamma-glutamyl tranClass IIJul 10, 2023Potential for reagent carryover on the Atellica CH 930 resul
Atellica¿ CH HDL Cholesterol- In vitro diagnostic use in the quantitative determination of HDL cholesterol in human seClass IIJul 10, 2023Potential for reagent carryover on the Atellica CH 930 resul
Atellica CH Total Bilirubin_2 -In vitro diagnostic use in the quantitative determination of total bilirubin in human seClass IIJul 10, 2023Potential for reagent carryover on the Atellica CH 930 resul
epoc BGEM Crea Test Card with epoc Host SW v3.37.3, epoc NXS SW v4.10.6, Sensor Configuration 41.1Class IIJun 1, 2023There is potential for discrepant high glucose results in sa
epoc BGEM Test Card (BUN & TCO2),Veterinary with epoc Host SW v3.37.3, epoc NXS SW v4.10.6, Sensor Configuration 41.1Class IIJun 1, 2023There is potential for discrepant high glucose results in sa
epoc BGEM BUN Test Card with epoc Host SW v3.37.3, epoc NXS SW v4.10.6, Sensor Configuration 41.1Class IIJun 1, 2023There is potential for discrepant high glucose results in sa
Aptio Automation Storage and Retrieval Module (SRM)Class IIMay 16, 2023A firmware error may lead to an incorrect association of tes
ADVIA Chemistry ToxAmmonia Calibrator- In vitro diagnostic use in the calibration of ethanol (ETOH_2), ammonia (AMM), acClass IIApr 5, 2023Reassignment of the Atellica CH Toxicology Calibrators (TOX
Atellica CH Toxicology Calibrator (TOX CAL)-The Atellica¿ CH Toxicology Calibrator (TOX CAL) is for in vitro diagnostic Class IIApr 5, 2023Reassignment of the Atellica CH Toxicology Calibrators (TOX
Atellica IM Cortisol 50T (Material Number 10995538), 250T (Material Number 10995537), and REF 250T (Material Number 1120Class IIMar 16, 2023There is a negative bias with urine patient samples and urin
ADVIA Centaur Cortisol 50T (Material Number 10994924), ADVIA Centaur Cortisol 250T (Material Number 10994926), and ADVIAClass IIMar 16, 2023There is a negative bias with urine patient samples and urin
Dimension Tacrolimus (TAC) Flex reagent cartridge-In vitro diagnostic test for the quantitative measurement of tacrolimuClass IIJan 30, 2023Siemens Healthineers has received customer complaints and co
Atellica CH Total Protein II- In vitro diagnostic use in the quantitative determination of total protein in human serum Class IIJan 27, 2023Reagent Carryover from LDL Cholesterol Direct (DLDL), Total
Atellica CH Triglycerides (concentrated)-In vitro diagnostic use in the quantitative measurement of triglycerides in humClass IIJan 27, 2023Reagent Carryover from LDL Cholesterol Direct (DLDL), Total
Atellica CH LDL Cholesterol Direct (DLDL)-In vitro diagnostic quantitative determination of LDL cholesterol in human serClass IIJan 27, 2023Reagent Carryover from LDL Cholesterol Direct (DLDL), Total
Atellica CH Triglycerides_2: in vitro diagnostic use in the quantitative determination of triglycerides in human serum aClass IIJan 27, 2023Reagent Carryover from LDL Cholesterol Direct (DLDL), Total
ADVIA Centaur Folate 100 test kit-For in vitro diagnostic use in the quantitative determination of folate in human serumClass IIJan 9, 2023Negative bias occurred when whole blood calibration (Atellic
Atellica IM Folate 700 test kit (REF)-For in vitro diagnostic use in the quantitative determination of folate in human sClass IIJan 9, 2023Negative bias occurred when whole blood calibration (Atellic
ADVIA Centaur Folate 500 test kit (REF)-For in vitro diagnostic use in the quantitative determination of folate in humanClass IIJan 9, 2023Negative bias occurred when whole blood calibration (Atellic
Atellica IM Folate 700 test kit- For in vitro diagnostic use in the quantitative determination of folate in human serum Class IIJan 9, 2023Negative bias occurred when whole blood calibration (Atellic
ADVIA Centaur Folate 500 test kit- For in vitro diagnostic use in the quantitative determination of folate in human seruClass IIJan 9, 2023Negative bias occurred when whole blood calibration (Atellic
Atellica IM Folate 140 test kit- For in vitro diagnostic use in the quantitative determination of folate in human serum Class IIJan 9, 2023Negative bias occurred when whole blood calibration (Atellic
ADVIA Centaur XP and ADVIA Centaur XPT Anti-HBe2 (aHBe2) 50T- In vitro diagnostic immunoassay for the qualitative detectClass IIDec 22, 2022Anti-HBe2 (aHBe2) interference with the Hepatitis B e Antige
epoc Host 2 as follows: Product SMN epoc NXS Host, US 11413475 epoc NXS Host, EU 11413497 epocClass IIDec 12, 2022pO2 High Recovery in Quality Control When Adjusted for Barom
epoc Host 2 as follows: Product SMN epoc Host 10736387 epoc Host 2, Canada 10736388 epoc Host 2, CClass IIDec 12, 2022pO2 High Recovery in Quality Control When Adjusted for Barom
IMMULITE 2000 Thyroglobulin (OUS). For in vitro diagnostic use with the IMMULITE 2000 Systems Analyzers for the quantiClass IIDec 7, 2022Potential for Functional Sensitivity to not meet Instruction
IMMULITE 2000 Thyroglobulin (US)- For in vitro diagnostic use with the IMMULITE 2000 Systems Analyzers (IMMULITE 2000/ Class IIDec 7, 2022Potential for Functional Sensitivity to not meet Instruction
IMMULITE 2000 Systems 3gAllergy Specific IgE Universal Kit Tests OUS, except Japan Siemens Material Number (SMN): 103Class IINov 4, 2022Potential for falsely elevated specific IgE mold allergen re
IMMULITE 2000 Systems 3gAllergy Specific IgE Universal Kit Tests (600T)- US. Siemens Material Number (SMN): 10708840 Class IINov 4, 2022Potential for falsely elevated specific IgE mold allergen re
IMMULITE 2000 Systems 3gAllergy Specific IgE Universal Kit Tests Japan Siemens Material Number (SMN): 10711939 ForClass IINov 4, 2022Potential for falsely elevated specific IgE mold allergen re
IMMULITE and IMMULITE 1000 Total Testosterone Assay- In vitro diagnostic use with the IMMULITE and IMMULITE 1000 AnalyzeClass IIOct 25, 2022Confirmed an average positive bias of 40% for testosterone c
Atellica CH Lithium_2 (LITH_2), Siemens Material Number 11532401. in vitro diagnostic assayClass IISep 19, 2022Potential for falsely elevated LITH_2 and Li results on the
Atellica CH Lithium (Li), Siemens Material Number 11097535. in vitro diagnostic assayClass IISep 19, 2022Potential for falsely elevated LITH_2 and Li results on the
N Antiserum to Human IgG, 5mL Variant for BN II System and BN ProSpec System- IVD Siemens Material Number (SMN): 104Class IIAug 30, 2022N Antiserum to Human IgG are not meeting the current High-Do
N Antiserum to Human IgG, 2mL Variant for BN II System and BN ProSpec System-IVD Siemens Material Number (SMN): 1044629Class IIAug 30, 2022N Antiserum to Human IgG are not meeting the current High-Do
Dimension Vista High Density Lipoprotein Cholesterol (HDLC) Flex reagent cartridge, IVD Siemens Material Number (SMN): Class IIAug 24, 2022Dimension Vista¿ High Density Lipoprotein Cholesterol (HDLC)
Dimension Magnesium (MG) Flex reagent cartridge Siemens Material Number (SMN)/REF (Catalog Number):10444963/DF57Class IIAug 17, 2022Dimension Magnesium (MG) Flex reagent cartridge lots may exh
IMMULITE 2000 and IMMULITE 2000 XPi Thyroid Stimulating Immunoglobulins (TSI) Siemens Material Number (SMN): 10876421 UClass IIAug 11, 2022An average negative bias of -23% with IMMULITE 2000/IMMULITE
Dimension Vista LOCI CA 15-3 Flex reagent cartridge. In Vitro Diagnostic for the quantitative measurement of CA 15-3. Class IIJul 18, 2022Negative bias with patient samples. The mean patient sample
Atellica CH Iron_2 (Iron_2) is for in vitro diagnostic use in the quantitative determination of iron in human serum andClass IIJun 28, 2022Falsely Elevated Atellica CH Microalbumin_2 (¿ALB_2) Results
epoc BGEM Test Card 25 Test Cards/box. In vitro diagnostic device for the quantitative testing of samples of heparinizeClass IIJun 1, 2022Discrepant (low bias) pO2 results, could be an incorrect dia
Dimension LTNI -In vitro diagnostic test intended to quantitively measure cardiac troponin-I levels in human serum and hClass IIMay 18, 2022Positive bias with Lithium Heparin plasma samples from indi
Dimension CTNI-In vitro diagnostic test intended to quantitively measure cardiac troponin-I levels in human serum and heClass IIMay 18, 2022Positive bias with Lithium Heparin plasma samples from indi
Atellica IM 1300 Analyzer - automated, immunoassay analyzer designed to perform in vitro diagnostic tests on clinical spClass IIApr 13, 2022Lots incompatible with Test Definition (TDef) Version 1.4,
Atellica IM 1600 Analyzer - automated, immunoassay analyzer designed to perform in vitro diagnostic tests on clinical spClass IIApr 13, 2022Lots incompatible with Test Definition (TDef) Version 1.4,
Atellica IM Enhanced Estradiol (eE2) 100T - In vitro diagnostic use in the quantitative determination of estradiol SMN: Class IIMar 3, 2022Falsely Elevated Results Observed with Plasma Specimens, cou
Atellica IM Enhanced Estradiol (eE2) (REF) 500T - In vitro diagnostic use in the quantitative determination of estradiolClass IIMar 3, 2022Falsely Elevated Results Observed with Plasma Specimens, cou
Atellica IM Enhanced Estradiol (eE2) 500T - In vitro diagnostic use in the quantitative determination of estradiol SMN: Class IIMar 3, 2022Falsely Elevated Results Observed with Plasma Specimens, cou
ADVIA Centaur Enhanced Estradiol (eE2) 500T - In vitro diagnostic use in the quantitative determination of estradiol SMNClass IIMar 3, 2022Falsely Elevated Results Observed with Plasma Specimens, cou
ADVIA Centaur Enhanced Estradiol (eE2) (REF) 500T - In vitro diagnostic use in the quantitative detection of estradiol SClass IIMar 3, 2022Falsely Elevated Results Observed with Plasma Specimens, cou
ADVIA Centaur Enhanced Estradiol (eE2) 100T - In vitro diagnostic use in the quantitative determination of estradiol SMNClass IIMar 3, 2022Falsely Elevated Results Observed with Plasma Specimens, cou
IMMULITE 2000 Systems HCG [200 Tests, material number 10381206, catalog number L2KCG] and [600 Tests, material number 10Class IIFeb 22, 2022Potential for falsely elevated hCG results due to sample car
Atellica CH Lithium_2 (LITH_2), Siemens Material Number 11097637Class IIFeb 9, 2022Siemens Healthcare Diagnostics Inc. has confirmed the potent
Atellica CH Calcium_2 (CA_2), Siemens Material Number 11097644Class IIFeb 9, 2022Siemens Healthcare Diagnostics Inc. has confirmed the potent
Atellica CH Enzymatic Hemoglobin A1c (A1c_E/A1c_H), Siemens Material Number 11097536Class IIFeb 9, 2022Siemens Healthcare Diagnostics Inc. has confirmed the potent
Atellica CH Fructosamine (Fruc), Siemens Material Number 11097637Class IIFeb 9, 2022Siemens Healthcare Diagnostics Inc. has confirmed the potent
Siemens Dimension Vista Magnesium Flex reagent cartridge (MG) Material # 10445158, Catalog # K3057 used in the DimensioClass IIJan 28, 2022Dimension Vista Magnesium Flex reagent cartridge lots exhibi
Atellica CH ¿2-Microglobulin (B2M) -M) Assay for in vitro diagnostic use in the quantitative determination of ¿2-microglClass IIDec 1, 2021¿2 Microglobulin (B2M) Reagent Lot 211446 Bias with Quality
Atellica CH 930 Analyzer with Software version: V1.25.1 and lower- An automated, clinical chemistry analyzer designed toClass IINov 18, 2021(1)Software (SW) versions V1.25.1 and lower may result in TD
Dimension Vista 1500 In-vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, miClass IIOct 15, 2021Incorrect Default Hemolysis, Icterus or Lipemia (HIL) Index
Dimension Vista 500- In-vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, miClass IIOct 15, 2021Incorrect Default Hemolysis, Icterus or Lipemia (HIL) Index
Aptio Automation Interface Module to ADVIA Centaur XP/XPT. Aptio by Siemens Centaur Interface Firmware (FW) CENa_3-1-0-1Class IIOct 6, 2021The Aptio Automation Firmware for the ADVIA Centaur XP/XPT I
Atellica IM 1600 Analyzer, SMN 11066000Class IISep 28, 2021Ancillary reagent packs used on Atellica IM 1300 and Atellic
Atellica IM 1300 Analyzer, SMN 11066001Class IISep 28, 2021Ancillary reagent packs used on Atellica IM 1300 and Atellic
ADVIA Centaur SARS-CoV-2 Antigen Assay (100 Test Kit), SMN # 11207866Class IISep 22, 2021Data provided in the Emergency Use Authorization (EUA) submi
Atellica IM SARS-CoV-2 Antigen Assay (100 Test Kit), SMN # 11207861Class IISep 22, 2021Data provided in the Emergency Use Authorization (EUA) submi
Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP), SMN 11097543Class IISep 20, 2021The firm has confirmed the potential for Atellica CH Urinary
Advia Chemistry Urinary/Cerebrospinal Fluid Protein (UCFP), SMN 11319151Class IISep 20, 2021The firm has confirmed the potential for ADVIA Chemistry Uri
Atellica IM BR 27.29 (BR) Assay 250 Test Kit- in vitro diagnostic use in the quantitative serial determination of cancerClass IIJul 6, 2021Product does not meet the Instructions for Use (IFU) claimed
Atellica IM BR 27.29 (BR) Assay 250 Test Kit (Reference)- in vitro diagnostic use in the quantitative serial determinatiClass IIJul 6, 2021Product does not meet the Instructions for Use (IFU) claimed
Atellica IM BR 27.29 (BR) Assay 50 Test Kit- in vitro diagnostic use in the quantitative serial determination of cancerClass IIJul 6, 2021Product does not meet the Instructions for Use (IFU) claimed
The ADVIA Chemistry XPT Chemistry System, Siemens Material Number (SMN) 10723034, is an automated, clinical chemistry anClass IIMay 18, 2021ADVIA Chemistry System and Software Versions (V1.4 SMN 11314
Atellica IM 1600 Analyzer- multi-component system for in vitro diagnostic testing of clinical specimens SMN 11066000Class IIMay 13, 2021Valves used on the Atellica CH 930, Atellica IM 1300 and Ate
Atellica CH 930 Analyzer - multi-component system for in vitro diagnostic testing of clinical specimens SMN 11067000Class IIMay 13, 2021Valves used on the Atellica CH 930, Atellica IM 1300 and Ate
Atellica IM 1300 Analyzer - multi-component system for in vitro diagnostic testing of clinical specimens SMN 11066001Class IIMay 13, 2021Valves used on the Atellica CH 930, Atellica IM 1300 and Ate
Atellica CH 930 Analyzer with Photometer Lamp (SMN 11075676) Siemens Material Number: 11067000Class IIMay 4, 2021Photometer Lamp May Reach Saturation Without Flagging Result
Centaur Syphilis Assay-SYP Kit, 200 Test - Product Usage: For in vitro diagnostic use in the qualitative determination oClass IIApr 21, 2021Potential for the ADVIA Centaur Syphilis assay to carryover
ADVIA 2120i Refurb Dual Aspirate (SMN 11314045) - OUS, automated hematology analyzer Software Versions 6.10 and 6.11Class IIMar 5, 2021Potential Sample Identification (SID) Mismatch with14-Charac
ADVIA 2120i (RoHS) Dual Aspirate Autosampler (SMN 11219530) - US, automated hematology analyzer Software Versions Class IIMar 5, 2021Potential Sample Identification (SID) Mismatch with14-Charac
ADVIA 2120 REFURB SAA AUTOSAMPLER (SMN 10374453) - OUS, automated hematology analyzer Software Versions 6.10 and 6.1Class IIMar 5, 2021Potential Sample Identification (SID) Mismatch with14-Charac
ADVIA 2120 REFURB DAA AUTOSAMPLER (SMN 10374454) - OUS, automated hematology analyzer Software Versions 6.10 and 6.1Class IIMar 5, 2021Potential Sample Identification (SID) Mismatch with14-Charac
ADVIA 2120i with Single Aspirate Autosampler (SMN 10488923) - US, automated hematology analyzer Software Versions 6.Class IIMar 5, 2021Potential Sample Identification (SID) Mismatch with14-Charac
ADVIA 2120 with Single Aspirate Autosampler (SMN 10316162) - US, automated hematology analyzer Software Versions 6.10 aClass IIMar 5, 2021Potential Sample Identification (SID) Mismatch with14-Charac
ADVIA 2120i (RoHS) with Single Aspirate Autosampler (SMN 11219529) - US, automated hematology analyzer Software VerClass IIMar 5, 2021Potential Sample Identification (SID) Mismatch with14-Charac
ADVIA 2120 REFURB SAA AUTOSAMPLER (SMN 10374453) - US, automated hematology analyzer -automated hematology analyzer Class IIMar 5, 2021Potential Sample Identification (SID) Mismatch with14-Charac
ADVIA 2120 REFURB DAA AUTOSAMPLER (SMN 10374454) - US, automated hematology analyzer Software Versions 6.10 and 6.1Class IIMar 5, 2021Potential Sample Identification (SID) Mismatch with14-Charac
ADVIA 2120i with Single Aspirate Autosampler (SMN 10488923) - OUS, automated hematology analyzer Software Versions 6Class IIMar 5, 2021Potential Sample Identification (SID) Mismatch with14-Charac
ADVIA 2120i Dual Aspirate Autosampler (SMN 10285573) - US, automated hematology analyzer Software Versions 6.10 andClass IIMar 5, 2021Potential Sample Identification (SID) Mismatch with14-Charac
ADVIA 2120i Refurb Single Aspirate (SMN 11314044) - US, automated hematology analyzer Software Versions 6.10 and 6.Class IIMar 5, 2021Potential Sample Identification (SID) Mismatch with14-Charac
ADVIA 2120i (RoHS) with Single Aspirate Autosampler (SMN 11219529) - OUS, automated hematology analyzer Software VerClass IIMar 5, 2021Potential Sample Identification (SID) Mismatch with14-Charac
ADVIA 2120i Dual Aspirate Autosampler (SMN 10285573) - OUS, automated hematology analyzer Software Versions 6.10 andClass IIMar 5, 2021Potential Sample Identification (SID) Mismatch with14-Charac
ADVIA 2120i (RoHS) Dual Aspirate Autosampler (SMN 11219530) - OUS, automated hematology analyzer Software Versions 6Class IIMar 5, 2021Potential Sample Identification (SID) Mismatch with14-Charac
ADVIA 2120 Dual Aspirate Autosampler (SMN 10313419) - US, automated hematology analyzer -automated hematology analyzClass IIMar 5, 2021Potential Sample Identification (SID) Mismatch with14-Charac
ADVIA 2120 Dual Aspirate Autosampler (SMN 10313419) - OUS, automated hematology analyzer Software Versions 6.10 and Class IIMar 5, 2021Potential Sample Identification (SID) Mismatch with14-Charac
ADVIA 2120i Refurb Dual Aspirate (SMN 11314045) - US, automated hematology analyzer Software Versions 6.10 and 6.11Class IIMar 5, 2021Potential Sample Identification (SID) Mismatch with14-Charac
ADVIA 2120i Refurb Single Aspirate (SMN 11314044) - OUS, automated hematology analyzer Software Versions 6.10 and 6.Class IIMar 5, 2021Potential Sample Identification (SID) Mismatch with14-Charac
ADVIA 2120 with Single Aspirate Autosampler (SMN 10316162) - OUS, automated hematology analyzer Software Versions 6.Class IIMar 5, 2021Potential Sample Identification (SID) Mismatch with14-Charac
BCS XP System: Multipurpose system for in vitro coagulation studies. Product code: 10459330, 10461894, 10470625 - ProducClass IIMar 2, 2021Siemens Healthcare Diagnostics Products GmbH has confirmed t
Enzyme linked immunosorbent assay, for herpes simplex virus, hsv-2Class IIFeb 8, 2021Potential false positive HSV results. Siemens Healthcare Di
Dimension Vista HDLC - colorimetric method, lipoproteins - Product Usage: used as an aid in the diagnosis of lipid disorClass IIFeb 3, 2021Siemens Healthcare Diagnostics Inc. has confirmed the potent

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