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Beckman Coulter Inc. FDA Recalls
112 recalls on file across devices, 0 of them Class I and 98 still open. This firm is not matched to a listed company.
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Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
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| Beckman Coulter DxC 500 AU Clinical Analyzer Modules using software version 1.5 or lower: 1) AU w/out ISE, Part NumbeClass IIJul 15, 2026a software defect in which the Parameter Package (PP) impor |
| Beckman Coulter DxC 500i Clinical Analyzer Modules using software version 1.5 or lower: 1) DxC 500 AU Module w/ISE, DClass IIJul 15, 2026a software defect in which the Parameter Package (PP) impor |
| REF # D23352, MicroScan LabPro V5.03 Panel Update 11 (US), Electronic installed on the following instruments: - B1018Class IIJun 26, 2026Analyzers contain incorrect algorithms which may affect anti |
| REF # D23354, MicroScan LabPro V5.03 Panel Update 11 DVD Kit (US) on the following instruments: - B1018-280 MicroScan Class IIJun 26, 2026Analyzers contain incorrect algorithms which may affect anti |
| Access Total T4 Calibrator, Catalog No. 33805Class IIMar 16, 2026Beckman Coulter has identified that Access Total T4 Calibrat |
| CellMek SPS Sample Preparation System, REF: C44603, with softwareClass IIDec 23, 2025Sample preparation system designed to automate staining, lys |
| Beckman Coulter UniCel Dxl 800, Part numbers: 973100, A71456, A71457, A25288; Immunoassay Method, Troponin SubunitClass IINov 26, 2025Beckman Coulter has determined that, due to a potential comm |
| Beckman Coulter UniCel Dxl 600, Part numbers: A71460, A71461, A30260; Immunoassay Method, Troponin SubunitClass IINov 26, 2025Beckman Coulter has determined that, due to a potential comm |
| COULTER DxH Diluent, REF 628017 COULTER DxH ECO Diluent REF C67250 For use as an isotonic buffered diluent in conjunClass IINov 10, 2025Due to specific lots of diluents contributing to elevated pl |
| Access 2 Reaction Vessels, individual, disposable, plastic tubes used to process patient, quality control and calibratioClass IINov 7, 2025It has been determined that certain lots of Access 2 Reactio |
| Beckman Coulter UniCel DxI 600, Part Numbers: A71460, A30260; Photometric Chemistry AnalyzerClass IIOct 1, 2025An internal investigation has determined that due to defecti |
| Beckman Coulter UniCel DxI 800, Part Numbers: 973100, A71456; Photometric Chemistry AnalyzerClass IIOct 1, 2025An internal investigation has determined that due to defecti |
| DxFLEX Flow Cytometer Catalog Number C78500 UDI-DI code: 15099590754013 The DxFLEX Flow Cytometer is intended for usClass IISep 22, 2025Due to a software error code that crashes during acquisition |
| DxC 500i Clinical Analyzer Modules, DxC 500 AU Module w/ISE, DxC 500i (Part Number C63522), DxC 500 AU Module, DxC 500i Class IISep 19, 2025Beckman Coulter has confirmed a software anomaly on DxI 9000 |
| DxI 9000 Access Immunoassay Analyzer, Part Number C11137Class IISep 19, 2025Beckman Coulter has confirmed a software anomaly on DxI 9000 |
| SYNCHRON Systems Direct LDL Cholesterol (LDLD) Reagent, REF: 969706Class IISep 17, 2025Beckman Coulter has identified that there is an increased pr |
| MicroScan Neg Multidrug Resistant MIC 1 REF C32368 UDI-DI code: 15099590720568 Intended Use- For use with MicroScan Class IISep 8, 2025Due to manufacturing issue (incorrectly processing) with in |
| CellMek SPS Sample Preparation System, REF: C44603. Software versions 2.2.122.0 and prior, and Instructions for Use (IFUClass IISep 8, 2025Automated pipetting, diluting and specimen processing workst |
| SYNCHRON Systems Phosphorus (PHOSm) Reagent REF: 467868 For In Vitro Diagnostic Use, Rx Only.Class IISep 3, 2025Specific SYNCHRON Systems Modular Chemistry Phosphorus (PHOS |
| UniCel DxH 600 COULTER Cellular Analysis System, configured with the Led HGB Photometer REF:B23858Class IIAug 13, 2025Hematology analyzers configured with HGB photometers may res |
| UniCel DxH 800 COULTER Cellular Analysis System, configured with the Led HGB Photometer REFs:B24802, 629029, B63322Class IIAug 13, 2025Hematology analyzers configured with HGB photometers may res |
| UniCel DxH 900 COULTER Cellular Analysis System, configured with the Led HGB Photometer REF: C11478Class IIAug 13, 2025Hematology analyzers configured with HGB photometers may res |
| UniCel DxH 690T COULTER Cellular Analysis System, configured with the Led HGB Photometer REF: C34520Class IIAug 13, 2025Hematology analyzers configured with HGB photometers may res |
| DxC 500 AU Module w/ISE, DxC 500i, With ISE, REF: C63522 and DxC 500 AU Module, DxC 500i, Without ISE, REF: C6352; part Class IIAug 4, 2025On a clinical analyzer, when ordering a Clinical Chemistry ( |
| MicroScan Neg MIC 56 REF C42464 UDI-DI code: 15099590731212 MicroScan panels are designed for use in determining antClass IIJul 24, 2025Due to the likely presence of contamination in well(s). |
| Access Thyroglobulin assay, a simultaneous one-step immunoenzymatic assay, Catalog Number 33860Class IIJul 10, 2025Access Thyroglobulin reagent lot 439163 may generate erroneo |
| UIBC (Unsaturated Iron Binding Capacity), REF: OSR61205,Class IIJun 26, 2025Beckman Coulter identified that the Unsaturated Iron Binding |
| UniCel DxI 800 Access Immunoassay Analyzer, Part Number 973100Class IIJun 25, 2025Beckman Coulter has identified that the UniCel DxI 600/800 s |
| UniCel DxI 600 Access Immunoassay Analyzer, Part Number A30260Class IIJun 25, 2025Beckman Coulter has identified that the UniCel DxI 600/800 s |
| MicroScan Neg MIC 3J REF C54814Class IIJun 25, 2025Due to a manufacturing issue - missing a drug in well 4/4 bu |
| DxI 600 Access Immunoassay Analyzer W/Spot B, Part Number A71460Class IIJun 25, 2025Beckman Coulter has identified that the UniCel DxI 600/800 s |
| DxI 600 Access Immunoassay Analyzer W/Dual Gantry, Part Number A71461Class IIJun 25, 2025Beckman Coulter has identified that the UniCel DxI 600/800 s |
| DxI 800 Access Immunoassay Analyzer W/Dual Gantry, Part Number A71457Class IIJun 25, 2025Beckman Coulter has identified that the UniCel DxI 600/800 s |
| DxI 800 Access Immunoassay Analyzer W/Spot B, Part Number A71456Class IIJun 25, 2025Beckman Coulter has identified that the UniCel DxI 600/800 s |
| Estrone RIA, REF: DSL8700. Estrone RIA is an IVD used for the quantitative measurement of estrone in human serum and plClass IIJun 12, 2025A specific lot of bovine serum albumin (BSA) used for manufa |
| DxI 9000 Access Immunoassay Analyzer C11137Class IIMay 7, 2025Analyzer has calibration issues where curves switched from p |
| Access Testosterone assay, Catalog Number 33560Class IIMay 5, 2025Inadequate preventative maintenance (PM) performed on the s |
| DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137, running software version 1.20Class IIApr 23, 2025A new software update (v1.20) is introducing error codes for |
| DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137, running software versions 1.20Class IIApr 23, 2025A new motor/encoder and cable was introduced into instrument |
| REMISOL Advance UDI-DI code: 13700962601874 All Software Versions: B92487; B92488; C24317; C28652; C37500; D04164; C4Class IIApr 8, 2025Due to a software issue, the software may incorrectly proces |
| Beckman Coulter DxI 9000 Access Immunoassay AnalyzerClass IIMar 27, 2025When DxI 9000 Access Immunoassay Analyzer is connected to a |
| DxC 500 AU Clinical Chemistry Analyzer, Catalog Numbers/UDI codes: C63519 / 14987666545058 C63520 / 14987666545065. Class IIMar 20, 2025Beckman Coulter is recalling their DxC 500 AU Clinical Chemi |
| DxC 500 AU Clinical Chemistry Analyzer, Catalog Numbers/UDI codes: C63519 / 14987666545058 C63520 / 14987666545065 Class IIMar 17, 2025The reason for the recall is incorrect sample barcode identi |
| Access Vitamin B12 Reagent, Catalog Number 33000, Lot Number 439850Class IIFeb 27, 2025Beckman Coulter has received complaints of erroneous Vitamin |
| DxC 500 AU Clinical Chemistry Analyzer, Catalog Numbers/UDI codes: C63519 / 14987666545058 C63520 / 14987666545065 Class IIFeb 26, 2025Beckman Coulter has determined that device software versions |
| DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137, with Component PCB, TSI/RSI firmware C29278Class IIFeb 6, 2025Beckman Coulter identified that an issue for DxI 9000 tip st |
| DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137.Class IIFeb 5, 2025the DxI 9000 encoder wheel was misaligned on the motor shaft |
| Access 2 Immunoassay Analyzer, Catalog Number 81600NClass IIFeb 5, 2025Beckman Coulter identified that an issue for Access 2 Sample |
| Access Erythropoietin (EPO), Catalog Number - A16364 a glycoprotein (~30,400 Daltons) produced primarily by the kidney,Class IIFeb 3, 2025Affected lot (439363) exhibited a negative dose drop of -22% |
| Access PCT Reagent Pack, Catalog Number C53987, when used on Access 2 and UniCel Dxl Immunoassay SystemsClass IIJan 2, 2025Identified reagent lots are experiencing a high rate of cali |
| Access Intact PTH assay, a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of intClass IINov 26, 2024Beckman Coulter has identified that some Access PTH reagent |
| Access hsTnI Reagent, REF B52699, Immunoassay Method, Troponin Subunit. For the quantitative determination of cardiac tClass IINov 18, 2024Beckman Coulter, Inc. is recalling their Access hsTnI assay, |
| DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137Class IINov 13, 2024The DxI 9000 Access Immunoassay Analyzer wash wheel mixer m |
| Access Intact PTH assay on the DxI 9000 Access Immunoassay Analyzer, Catalog number A16972, for the quantitative determiClass IINov 8, 2024The reason for the recall is that EDTA and lithium heparin p |
| The Access Cortisol assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination oClass IISep 30, 2024The Access Cortisol assay protocol file (APF) applies an inc |
| Access Thyroglobulin Antibody II, REF A32898, containing Instructions for Use, IFU REF B14994, B63978, and A38168. The Class IISep 5, 2024IFUs for the device incorrectly states the biotin interferen |
| The Access TSH (3rd IS) assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative etermdinatioClass IIAug 28, 2024Certain lots of Access TSH reagent packs may produce erroneo |
| IMMAGE Immunochemistry Systems IGM Immunoglobulin M Reagent REF 447610 IGM reagent, when used in conjunction with IMMClass IIJul 31, 2024Firm identified two lots of reagents that are not meeting th |
| Beckman Coulter IRISPEC CA/CB/CC Urine Chemistry Controls, Catalog Number REF 800-7211 and 800-7702, in vitro diagnosticClass IIIJul 16, 2024Beckman Coulter has become aware of an increase in customer |
| DxI 9000 Access Immunoassay Analyzer, catalog number C11137 in vitro diagnostic device used for the quantitative, seClass IIJul 12, 2024Ground screws on Dxl 9000 PCB boards may cause electric shor |
| Beckman Coulter DxI 9000 Access Immunoassay Analyzer, Model Number C21510, RSM Pneumatic Tubing Kit item #2, REF C11137;Class IIJul 10, 2024Beckman Coulter is recalling the DxI 9000 Access Immunoassay |
| Discrete photometric chemistry analyzer for clinical use.Class IIJun 14, 2024Beckman Coulter, Inc. has identified a rise in reagent carou |
| Dxl 9000 Access Immunoassay Analyzer, Catalog #C11137.Class IIJun 4, 2024The analyzers were built with nonconforming USB cables made |
| Beckman Coulter, REF: OSR61173, IGM 4x14 mL R1, 4x11 mL R2Class IIMay 27, 2024LIH Influence check settings for Lipemia are incorrect which |
| Beckman Coulter DxI 9000 Access Immunoassay Analyzer, Catalog #C11137.Class IIMay 22, 2024The reason for this recall is Beckman Coulter has determined |
| DxI 9000 Access Immunoassay Analyzer, Catalog #C11137.Class IIMay 22, 2024When a DxI 9000 Access Immunoassay Analyzer is connected to |
| Beckman Coulter Dxl 9000 Access Immunoassay Analyzer, REF #C11137. An in vitro diagnostic device used for the quantitatiClass IIApr 18, 2024When the DxI 9000 Access Immunoassay Analyzer with system so |
| DxI 9000 Access Immunoassay Analyzer, C11137; in-vitro diagnosticClass IIApr 18, 2024Beckman Coulter is recalling their DxI 9000 Access Immunoass |
| DxI 9000 Access Immunoassay Analyzer, REF C11137, vitro diagnostic device used for the quantitative, semi-quantitative, Class IIMar 5, 2024Beckman Coulter manufacturing discovered cracks around a thr |
| Beckman Coulter DxI 9000 Access Immunoassay Analyzer is a discrete photometric chemistry analyzer for clinical use. It Class IIFeb 29, 2024The reason for the recall is the pneumatic tubing used in th |
| Access Total T4, REF 33800, IVD, thyroxine reagent assay.Class IIFeb 8, 2024Four lots of Access Total T4 reagent lots demonstrated impre |
| Access Substrate, REF 81906, For use with the Access Immunoassay SystemsClass IIFeb 7, 2024On 07 February 2024 Beckman Coulter made the decision to con |
| Beckman Coulter DxI 9000 Access Immunoassay Analyzer, catalog number C11137; in-vitro diagnostic instrumentClass IIJan 3, 2024A software error caused an increase in tray gripper motion e |
| Beckman Coulter DxU 850m/840m Microscopy Analyzers, Part Numbers: C49513, C76947Class IIDec 19, 2023Beckman Coulter has become aware that the cannula, which is |
| iQ Waste Well Adapter, Part Number: 700-3393Class IIDec 19, 2023Beckman Coulter has become aware that the cannula, which is |
| REV 2 Flowcell Capsule Spare, Part Number: C04154Class IIDec 19, 2023Beckman Coulter has become aware that the cannula, which is |
| iQ200 Series Urine Microscopy Analyzers, Part Numbers: a) 700-3320, b) 700-3370, c) 700-3345, d) 700-3347, e) Class IIDec 19, 2023Beckman Coulter has become aware that the cannula, which is |
| Access Ultrasensitive Insulin only used on the DxI 9000 Access Immunoassay Analyzer, Catalog Number 33410Class IINov 21, 2023There is an issue with the Access Ultrasensitive Insulin ass |
| DxI 9000 Access Immunoassay Analyzer running software version 1.16 or prior,Class IINov 21, 2023There are potential performance issues found in the DxI 9000 |
| DxI 9000 Access Immunoassay Analyzer, REF C11137, Sofware Versions 1.15 and below; invitro diagnosticClass IISep 12, 2023The firm has investigated and confirmed that when DxI 9000 i |
| Beckman Coulter, IVD, REF: OSR61171, IgA, 4 x 14 mL R1, 4 x 11 mL R2Class IIJul 12, 2023Lipemic interference failed to meet the performance specific |
| Access Thyroglobulin CalibratorsClass IIJul 6, 2023It has been determined through an internal investigation tha |
| Ringed DxI Reaction Vessels (RVs)Class IIJun 20, 2023Beckman Coulter, Inc. is recalling Ringed DxI Reaction Vesse |
| COULTER DxH Diluent, REF 628017; diluent used for counting and sizing blood cellsClass IIMay 31, 2023Specific diluent lot numbers showed that conductivity, osmol |
| Access Hybritech p2PSA reagent, REF B03704 and REF A49752.Class IIMay 17, 2023Reagent lot numbers include an insufficient concentration of |
| Beckman Coulter Bicarbonate, REF: OSR6237, 4x50 mLClass IIApr 5, 2023There is a potential for a decrease in calibration ODs for B |
| Beckman Coulter Bicarbonate, REF: OSR6137, 4x25 mLClass IIApr 5, 2023There is a potential for a decrease in calibration ODs for B |
| Beckman Coulter Bicarbonate, REF: OS6637, 4x173 mLClass IIApr 5, 2023There is a potential for a decrease in calibration ODs for B |
| DxU 850m Iris Urine Microscopy Analyzer Catalog Number C49513, in-vitro diagnostic device, urine analysisClass IIApr 5, 2023Beckman Coulter has become aware of an intermittent issue in |
| DxU 840m Iris Urine Microscopy Analyzer, Catalog Number C76947, in-vitro diagnostic device, urine analysisClass IIApr 5, 2023Beckman Coulter has become aware of an intermittent issue in |
| iQ200 Series Urine Microscopy Analyzer: a) iQ 200 Select, Part Numbers C10684 and 700-3345; b) iQ 200 Elite, Part NumbeClass IIApr 5, 2023Beckman Coulter has become aware of an intermittent issue in |
| UA WIN 10 Kit, Catalog Number C52900, in-vitro diagnostic device, urine analysisClass IIApr 5, 2023Beckman Coulter has become aware of an intermittent issue in |
| Beckman Coulter Access Free T3, Triiodothyronine, Free, Catalog #A13422, each box contains 2 reagent packs.Class IIMar 15, 2023The reagent lot produces elevated results (approximately >30 |
| Access Immunoassay Systems (1) Access 2 Immunoassay Analyzer (81600N); (2) Access 2 Immunoassay Analyzer, RefurbisheClass IIJan 26, 2023An increased incidence of damage to the nut band from a new |
| BECKMAN COULTER IRISpec CA/CB/CC control, REF 900-7211, For in vitro diagnostic use only.Class IINov 18, 2022Beckman Coulter has become aware of an increase in customer |
| MicroScan autoSCAN-4 Instrument, Catalog Number B1018-280Class IIOct 3, 2022Due to MicroScan autoSCAN-4 Instruments being manufactured w |
| Beckman Coulter IRISpec CA/CB/CC control, Catalog #800-7211, containing 3 x 100 mL bottles each of CA Control, CB ControClass IIIFeb 16, 2022IRISpec CA failures for glucose. |
| AU/DxC AU Magnesium, Catalog/REF Number OSR6189, UDI 15099590010850Class IIDec 8, 2021Lipemic interference for the Magnesium serum application fai |
| SYNCHRON Systems Cholesterol (CHOL) Reagent, REF: 467825Class IINov 10, 2021Cholesterol Reagent may fail with Out of Calibration Range L |
| Access hsTnI High Sensitivity Troponin I, REF B52699 Access Immunoassay System REAGENT PACKClass IIAug 9, 2021Through customer feedback, testing a sample with cardiac tro |
| Access SARS CoV-2 IgG (1st IS) Assay: Access Immunoassay Systems REAGENT PACK, REF C74339 Access SARS-CoV-2 IgG (1Class IIAug 5, 2021Firm's submission for Emergency Use Authorization (EUA) cont |
| Power Processor 3K, 3K High Speed Stockyards Module Nameplate: PP 3K Stockyard (Refrig) 9707 REF A88116Class IIJul 28, 2021Missing splash guard which may expose users to hazardous mat |
| DxA 5000 (DxA Automation System, DxA 5000 fit), "For in Vitro Diagnostic Use", Reference Numbers: B87352 with B57634, UDClass IIJul 21, 2021There is a potential that sample carriers (w or w/o samples) |
| Normand Remisol Advance Data Manager, REF: C69412, C69413, C44703, and C57017 is a software device that interfaces betweClass IIJul 15, 2021There is a potential that the data management system may add |
| Access SARS-CoV-2 Antigen Calibrators, Catalog, REF: C68669, Contents: 1x2.5 mL C0, 1x2.5mL C1, 1x CAL CARD, UDI: (01Class IIJul 1, 2021SARS-CoV-2 Antigen Assay test may generate false positive re |
| ACCESS SARS-CoV-2 Antigen , REF: C68668, IVD, Rx only, UDI: (01) 15099590742713;Class IIJul 1, 2021SARS-CoV-2 Antigen Assay test may generate false positive re |
| ACCESS SARS-CoV-2 ANTIGEN QC, REF: C68670, CONTENTS: 3 X 6.0 mL QC1, 3 x 6.0 mL QC2, 1 QC VALUE CARD, IVD, Rx Only, UDI:Class IIJul 1, 2021SARS-CoV-2 Antigen Assay test may generate false positive re |
| ACCESS SARS-CoV-2 ANTIGEN EXTRACTION SOLUTION, CONTENTS: 6 x 6.0 mL EXTRACTION SOLN, IVD, Rx Only, UDI: (01)15099590743Class IIJul 1, 2021SARS-CoV-2 Antigen Assay test may generate false positive re |
| Kaluza C Flow Cytometry Software Versions: 1.0*, 1.1.1 and 1.1.2 Kits: C10574 - Kaluza C Single Perpetual License C1Class IIJun 23, 2021Software anomalies that may lead to the generation of errone |
| Access SARS-CoV-2 lgG II Calibrator, REF C69058, IVD, CE UDI: (01)15099590742751Class IIMay 7, 2021SARS-CoV-2 lgG II numerical results may potentially be mul |
| Access SARS CoV-2 lgG II Reagent, REF: C69057, IVD CE UDI: (01)15099590742744Class IIMay 7, 2021SARS-CoV-2 lgG II numerical results may potentially be mul |
| Access SARS-CoV-2 Antigen, REF C68668, UDI: (01)15099590742713, 3.30 mL/R1a, 4.70 mL/R1b, 4.20 mL/R1c, 3.10 mL, R1d, 3.1Class IIApr 14, 2021specimens collected in transport media may result is false n |