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Biomerieux Inc FDA Recalls
127 recalls on file across devices, 1 of them Class I and 119 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 |
|---|
| VITEK 2 AST-N461 TEST KIT, GRAM NEGATIVE SUSCEPTIBILITY TESTING - AUTOMATED, Reference Number 424811Class IIJul 24, 2026The issue is related to card pouch damage associated with a |
| VITEK 2 AST-N447 TEST KIT Product reference 424620Class IIJun 4, 2026Potential for false resistant carbapenem and/or cephalospori |
| VITEK 2 Gram-negative Susceptibility Cards Containing o Polymyxin B (pb02n) o Ceftazidime/avibactam (cza02n) o MeropenemClass IIJan 5, 2026Potential risk of Quality Control failures and/or false resi |
| VITEK¿ 2 Gram-negative AST Test Kits (Cards) containing Colistin formulation cs02n. VITEK¿ 2 is an automated system cClass IIJun 26, 2025Potential for false resistant results for Colistin (cs02n) w |
| VITEK 2 - AST Test kits (in vitro diagnostic test cards for antimicrobial susceptibility): a) AST-N334, REF 418984; Class IMar 14, 2024Ceftriaxone (cro02n) concentration errors associated with sp |
| MYLA comprises AST Filters in conjunction with VITEK MS; middleware which connects microbiology laboratory instruments Class IIFeb 6, 2023For users with MYLA V4.8.X / V4.9 that use VITEK MS to ident |
| API 20 C AUX 25 STRIPS+25 MEDIA, CATALOG 20210Class IINov 9, 2022As the temperature and time out of range was exceeded, produ |
| PPM LOMBARD PRODUCTS TSA 10PLT, CATALOG M1040Class IINov 9, 2022As the temperature and time out of range was exceeded, produ |
| ETEST CLINICAL ERAVACYCLINE ERV US S30, CATALOG 421553Class IINov 9, 2022As the temperature and time out of range was exceeded, produ |
| VIDAS CLINICAL VIDAS RUB IGG 60 TESTS, CATALOG 30226Class IINov 9, 2022As the temperature and time out of range was exceeded, produ |
| VIDAS CLINICAL VIDAS SALMONELLA 60T, CATALOG 30702Class IINov 9, 2022As the temperature and time out of range was exceeded, produ |
| GENE-UP REAGENT GENE-UP Salmonella 2, CATALOG 423105Class IINov 9, 2022As the temperature and time out of range was exceeded, produ |
| PREVI COLOR GRAM REAGENT NOZZLE CLEANING SOLUTION (NA), CATALOG 29588Class IINov 9, 2022As the temperature and time out of range was exceeded, produ |
| VITEK 2 REAGENT AST-XN09 TEST KIT 20 CARDS, CATALOG 423425Class IINov 9, 2022As the temperature and time out of range was exceeded, produ |
| PPM LOMBARD PRODUCTS R2A MEDIUM 10PLT, CATALOG M1065Class IINov 9, 2022As the temperature and time out of range was exceeded, produ |
| ETEST CLINICAL CEFTAZIDIM/AVIBACTAM US S30, CATALOG 419046Class IINov 9, 2022As the temperature and time out of range was exceeded, produ |
| VITEK 2 REAGENT AST-GN81 TEST KIT 20 CARDS, CATALOG 413438Class IINov 9, 2022As the temperature and time out of range was exceeded, produ |
| VITEK 2 REAGENT AST-GN99 TEST KIT 20 CARDS, CATALOG 423102Class IINov 9, 2022As the temperature and time out of range was exceeded, produ |
| VITEK 2 REAGENT AST-ST02 TEST KIT 20 CARDS, CATALOG 420915Class IINov 9, 2022As the temperature and time out of range was exceeded, produ |
| PPM CLINICAL CRAPONNE CLINICAL CHROMID CANDIDA 20 PLATES, CATALOG 43631Class IINov 9, 2022As the temperature and time out of range was exceeded, produ |
| API NIT1 NIT2 REAGENTS, CATALOG 70442Class IINov 9, 2022As the temperature and time out of range was exceeded, produ |
| API VP1 VP2 REAGENTS, CATALOG 70422Class IINov 9, 2022As the temperature and time out of range was exceeded, produ |
| BIOBALL K.RHIZOPHILA (30X20), CATALOG 412690Class IINov 9, 2022As the temperature and time out of range was exceeded, produ |
| VIDAS CLINICAL VIDAS LH 60 TESTS, CATALOG 30406-01Class IINov 9, 2022As the temperature and time out of range was exceeded, produ |
| VITEK 2 REAGENT AST-XN15 TEST KIT 20 CARDS, CATALOG 423829Class IINov 9, 2022As the temperature and time out of range was exceeded, produ |
| VIDAS CLINICAL QCV-QUALITY CONTROL VIDAS 60T, CATALOG 30706Class IINov 9, 2022As the temperature and time out of range was exceeded, produ |
| VITEK 2 REAGENT BCL TEST KIT VTK2 20 CARDS, CATALOG 21345Class IINov 9, 2022As the temperature and time out of range was exceeded, produ |
| BIOBALL P.AERUGINOSA NCTC 12924 550X20, CATALOG 56017Class IINov 9, 2022As the temperature and time out of range was exceeded, produ |
| VIDAS CLINICAL VIDAS LISTERIA 60T, CATALOG 30700Class IINov 9, 2022As the temperature and time out of range was exceeded, produ |
| PPM CLINICAL CHROMID MRSA 20 PLT US, CATALOG 43841Class IINov 9, 2022As the temperature and time out of range was exceeded, produ |
| PPM LOMBARD PRODUCTS TSA 3P W NEUTRALIZERS 100 PLT, CATALOG 423723Class IINov 9, 2022As the temperature and time out of range was exceeded, produ |
| ETEST CLINICAL MEROPENEM MP 32 US S30, CATALOG 412401Class IINov 9, 2022As the temperature and time out of range was exceeded, produ |
| VITEK 2 REAGENT AST-GN79 TEST KIT 20 CARDS, CATALOG 413436Class IINov 9, 2022As the temperature and time out of range was exceeded, produ |
| VITEK 2 REAGENT AST-GP78 TEST KIT 20 CARDS, CATALOG 421051Class IINov 9, 2022As the temperature and time out of range was exceeded, produ |
| PPM CLINICAL CHROMID STREPTO B US 20 PLT, CATALOG 419751Class IINov 9, 2022As the temperature and time out of range was exceeded, produ |
| ETEST CLINICAL MINOCYCLINE MC 256 US S30, CATALOG 412407Class IINov 9, 2022As the temperature and time out of range was exceeded, produ |
| PPM LOMBARD PRODUCTS T PHOSPHATE BUFFERSTERILE 20X9ML, CATALOG T8035Class IINov 9, 2022As the temperature and time out of range was exceeded, produ |
| PPM LOMBARD PRODUCTS TSA 3P W NEUTRALIZERS 100 PLT, CATALOG 419014Class IINov 9, 2022As the temperature and time out of range was exceeded, produ |
| VITEK 2 REAGENT AST-GN73 TEST KIT 20 CARDS, CATALOG 413404Class IINov 9, 2022As the temperature and time out of range was exceeded, produ |
| ETEST CLINICAL IMIPENEM IP 32 US S30, CATALOG 412373Class IINov 9, 2022As the temperature and time out of range was exceeded, produ |
| PPM INDUSTRY COMBOURG LPT BROTH (4X3L), CATALOG 410849Class IINov 9, 2022As the temperature and time out of range was exceeded, produ |
| PPM CLINICAL CHROMID MRSA S AUREUS 20PLT US, CATALOG 414524Class IINov 9, 2022As the temperature and time out of range was exceeded, produ |
| VITEK 2 REAGENT AST-GN69 TEST KIT 20 CARDS, CATALOG 413400Class IINov 9, 2022As the temperature and time out of range was exceeded, produ |
| ETEST CLINICAL VANCOMYCIN VA 256 US S30, CATALOG 412486Class IINov 9, 2022As the temperature and time out of range was exceeded, produ |
| ETEST CLINICAL BENZYLPENICIL PG 256 US S30, CATALOG 412262Class IINov 9, 2022As the temperature and time out of range was exceeded, produ |
| BIOBALL A.BRASILIENSIS NCPF 2275 550X20, CATALOG 56011Class IINov 9, 2022As the temperature and time out of range was exceeded, produ |
| VITEK 2 REAGENT AST-GN70 TEST KIT 20 CARDS, CATALOG 413401Class IINov 9, 2022As the temperature and time out of range was exceeded, produ |
| PPM CLINICAL CRAPONNE CHROMID C.DIFFICILE 20 PLT, CATALOG 43871Class IINov 9, 2022As the temperature and time out of range was exceeded, produ |
| VITEK 2 REAGENT AST-GP67 TEST KIT 20 CARDS, CATALOG 22226Class IINov 9, 2022As the temperature and time out of range was exceeded, produ |
| ETEST CLINICAL ERTAPENEM ETP 32 US S30, CATALOG 412331Class IINov 9, 2022As the temperature and time out of range was exceeded, produ |
| ETEST CLINICAL AMOXI/CLAV 2/1 XL 256 US S30, CATALOG 412240Class IINov 9, 2022As the temperature and time out of range was exceeded, produ |
| PPM LOMBARD PRODUCTS IR&DB - TSA (32ML) 10PLT, CATALOG M1205-IRClass IINov 9, 2022As the temperature and time out of range was exceeded, produ |
| VITEK 2 REAGENT GP TEST KIT VTK2 20 CARDS, CATALOG 21342Class IINov 9, 2022As the temperature and time out of range was exceeded, produ |
| VIDAS CLINICAL VIDAS PROGESTERONE 60 TESTS, CATALOG 30409-01Class IINov 9, 2022As the temperature and time out of range was exceeded, produ |
| ETEST CLINICAL AMOXI/CLAV 2/1 XL 256 US S30, CATALOG 412252Class IINov 9, 2022As the temperature and time out of range was exceeded, produ |
| VIDAS CLINICAL VIDAS MEASLES IGG 60TESTS, CATALOG 30219Class IINov 9, 2022As the temperature and time out of range was exceeded, produ |
| API STAPH 25 STRIPS+25 MEDIA, CATALOG 20500Class IINov 9, 2022As the temperature and time out of range was exceeded, produ |
| ASTUTE REAGENT ASTUTE ELECTRONIC QUALITY CTRL DEVICE US, CATALOG 400016Class IINov 9, 2022As the temperature and time out of range was exceeded, produ |
| VIDAS CLINICAL VIDAS BRAHMS PROCALCITONIN 60T, CATALOG 30450-01Class IINov 9, 2022As the temperature and time out of range was exceeded, produ |
| TEMPO REAGENTS TEMPO CONTROL KIT , CATALOG 80000Class IINov 9, 2022As the temperature and time out of range was exceeded, produ |
| ETEST CLINICAL FLUCONAZOLE FL 256 US S30, CATALOG 412333Class IINov 9, 2022As the temperature and time out of range was exceeded, produ |
| ETEST CLINICAL ETEST VANCOMYCIN VA M100 US, CATALOG 423788Class IINov 9, 2022As the temperature and time out of range was exceeded, produ |
| ETEST CLINICAL IMIPENEM RELEBACTAM IPR US S30, CATALOG 420927Class IINov 9, 2022As the temperature and time out of range was exceeded, produ |
| ETEST CLINICAL CEFTOLOZANE/TAZO C/T US S30, CATALOG 414445Class IINov 9, 2022As the temperature and time out of range was exceeded, produ |
| VIDAS CLINICAL VIDAS ESTRADIOL II 60 TESTS, CATALOG 30431-01Class IINov 9, 2022As the temperature and time out of range was exceeded, produ |
| PPM INDUSTRY COMBOURG BACARA 20PLATES 90MM, CATALOG AEB520100Class IINov 9, 2022As the temperature and time out of range was exceeded, produ |
| ETEST CLINICAL ERYTHROMYCIN EM 256 US S30, CATALOG 412333Class IINov 9, 2022As the temperature and time out of range was exceeded, produ |
| ETEST CLINICAL TOBRAMYCIN TM 256 US S30, CATALOG 412478Class IINov 9, 2022As the temperature and time out of range was exceeded, produ |
| PREVI COLOR GRAM REAGENT IODINE-B (NA), CATALOG 29586Class IINov 9, 2022As the temperature and time out of range was exceeded, produ |
| VITEK 2 REAGENT AST-GN95 TEST KIT 20 CARDS, CATALOG 421982Class IINov 9, 2022As the temperature and time out of range was exceeded, produ |
| VITEK MS CLINICAL REAGENT VITEK MS-CHCA, CATALOG 411071Class IINov 9, 2022As the temperature and time out of range was exceeded, produ |
| API 20 E 25 STRIPS, CATALOG 20100Class IINov 9, 2022As the temperature and time out of range was exceeded, produ |
| BIOBALL B.SPIZIZENII NCTC 10400 550X20, CATALOG 56012Class IINov 9, 2022As the temperature and time out of range was exceeded, produ |
| ASTUTE REAGENT NEPHROCHECK LIQUID CONTROLS KIT US, CATALOG 500013Class IINov 9, 2022As the temperature and time out of range was exceeded, produ |
| PPM LOMBARD PRODUCTS CT&IR&DB-TSA + L & P80 10PLT, CATALOG C6045-IRClass IINov 9, 2022As the temperature and time out of range was exceeded, produ |
| PPM LOMBARD PRODUCTS CT&TI-TSA + L & P80 10PLT, CATALOG C6045-TIClass IINov 9, 2022As the temperature and time out of range was exceeded, produ |
| VITEK MS CLINICAL REAGENT VITEK MS-FA, CATALOG 411072Class IINov 9, 2022As the temperature and time out of range was exceeded, produ |
| VITEK 2 REAGENT YST TEST KIT VTK2 20 CARDS, CATALOG 21343Class IINov 9, 2022As the temperature and time out of range was exceeded, produ |
| ETEST CLINICAL CEFTRIAXONE TX 32 US S30, CATALOG 412302Class IINov 9, 2022As the temperature and time out of range was exceeded, produ |
| PPM CLINICAL CRAPONNE CHROMID VRE 20 PLT US, CATALOG 43851Class IINov 9, 2022As the temperature and time out of range was exceeded, produ |
| VITEK 2 REAGENT AST-GP75 TEST KIT 20 CARDS, CATALOG 415670Class IINov 9, 2022As the temperature and time out of range was exceeded, produ |
| PPM INDUSTRY COMBOURG CHROMID CARBA US 20 PLT, CATALOG 414012Class IINov 9, 2022As the temperature and time out of range was exceeded, produ |
| DCOUNT SYSTEMS REAGENTS CHEMCHROME V14 (6X1.8ML), CATALOG 306-R1026-01Class IINov 9, 2022As the temperature and time out of range was exceeded, produ |
| ETEST CLINICAL LEVOFLOXACIN LE 32 US S30, CATALOG 412392Class IINov 9, 2022As the temperature and time out of range was exceeded, produ |
| VITEK 2 REAGENT AST-N801 TEST KIT 20 CARDS, CATALOG 423416Class IINov 9, 2022As the temperature and time out of range was exceeded, produ |
| ETEST CLINICAL COLISTIN CO 256 US B100, CATALOG 537348Class IINov 9, 2022As the temperature and time out of range was exceeded, produ |
| VITEK 2 REAGENT NH TEST KIT VTK2 20 CARDS, CATALOG 21346Class IINov 9, 2022As the temperature and time out of range was exceeded, produ |
| VITEK 2 REAGENT AST-GN80 TEST KIT 20 CARDS, CATALOG 413437Class IINov 9, 2022As the temperature and time out of range was exceeded, produ |
| PPM LOMBARD PRODUCTS IRR COUNT-TACT 3P AGAR 100 PLT, CATALOG 418049Class IINov 9, 2022As the temperature and time out of range was exceeded, produ |
| ETEST CLINICAL AMIKACIN AK 256 US S30, CATALOG 412218Class IINov 9, 2022As the temperature and time out of range was exceeded, produ |
| ETEST CLINICAL RIFAMPICIN RI 32 US S30, CATALOG 412449Class IINov 9, 2022As the temperature and time out of range was exceeded, produ |
| API JAMES 2AMP, CATALOG 70542Class IINov 9, 2022As the temperature and time out of range was exceeded, produ |
| ETEST CLINICAL ETEST MEROPENEM/VABORBACTAM MEV US S30, CATALOG 421560Class IINov 9, 2022As the temperature and time out of range was exceeded, produ |
| VITEK 2 REAGENT GN TEST KIT VTK2 20 CARDS, CATALOG 21341Class IINov 9, 2022As the temperature and time out of range was exceeded, produ |
| VIDAS CLINICAL VIDAS HCG 60 TESTS, CATALOG 30405-01Class IINov 9, 2022As the temperature and time out of range was exceeded, produ |
| VITEK MS CLINICAL REAGENT VITEK MS-DS, CATALOG 410893Class IINov 9, 2022As the temperature and time out of range was exceeded, produ |
| VIDAS CLINICALVIDAS VARICEL. ZOSTER IGG 60 T, CATALOG 30217Class IINov 9, 2022As the temperature and time out of range was exceeded, produ |
| API LISTERIA 10 STRIPS+10 MEDIA, CATALOG 10300Class IINov 9, 2022As the temperature and time out of range was exceeded, produ |
| GENE-UP REAGENT GENE-UP LYSIS KIT, CATALOG 414057Class IINov 9, 2022As the temperature and time out of range was exceeded, produ |
| ETEST CLINICAL ETEST MEROPENEM MP M100 US, CATALOG 423786Class IINov 9, 2022As the temperature and time out of range was exceeded, produ |
| NUCLISENS easyMAG Magnetic Silica, REF 280133, 24 x 1.2mL bottles/kit.Class IIJul 20, 2022There is a potential of no result leading to possible delaye |
| VITEK 2 / MYLA VITEK 2 Software versions 8.01, 8.02 (veterinary use only), 9.01, 9.02, 9.03 MYLA Software versions VClass IIJul 13, 2022There are 7 reported software anomalies that may affect use |
| VITEK 2 Systems and VITEK 2 with MYLA.Class IIMar 29, 2022Software issue where results sent to the LIS via HL7 format |
| VIDAS CMV IgM, 30 tests, REF 30205-01, IVD, Rx.Class IIFeb 9, 2022Invalid calibrations (out of range high) while using the pro |
| API ID 32 C Strips, Reference 32200, Rx Only, IVD API ID 32 C is a qualitative standardized system for the identificaClass IIDec 20, 2021Risk of misidentification or delayed results with the absenc |
| RAPID 20 E, REF 20701, System for the identification of Enterobacteriaceae in 4 hours, 25 strips/package, IVD.Class IINov 9, 2021There is an error in the new version of the package insert. |
| API 50 CH, Model 50300Class IISep 30, 2021There is potential to provide an incorrect organism identifi |
| VIDAS Clostridium Difficile Toxin A&B, CDAB,REF 30118-01Class IISep 22, 2021bioMerieux has been receiving an increasing number of compla |
| VIDAS Mumps IgG (MPG), REF 30218Class IISep 22, 2021bioMerieux has been receiving an increasing number of compla |
| VIDAS Measles IgG (MSG), REF 30219Class IISep 22, 2021bioMerieux has been receiving an increasing number of compla |
| VIDAS TOXO IgG Avidity (TXGA), REF 30222-01Class IISep 22, 2021bioMerieux has been receiving an increasing number of compla |
| VIDAS SARS-COV-2 IgG, Ref 423834-01Class IISep 22, 2021bioMerieux has been receiving an increasing number of compla |
| VIDAS FSH, REF 30407-01Class IISep 22, 2021bioMerieux has been receiving an increasing number of compla |
| VIDAS SARS-COV-2 IgM, Ref 423833-01Class IISep 22, 2021bioMerieux has been receiving an increasing number of compla |
| VIDAS Clostridium Difficile GDH, REF 30125-01Class IISep 22, 2021bioMerieux has been receiving an increasing number of compla |
| VIDAS RUB IgG (RBG), REF 30226Class IISep 22, 2021bioMerieux has been receiving an increasing number of compla |
| VIDAS LH, REF 30406-01Class IISep 22, 2021bioMerieux has been receiving an increasing number of compla |
| VIDAS Lyme IgG II (LYM), REF 417401Class IISep 22, 2021bioMerieux has been receiving an increasing number of compla |
| VIDAS DEX@, Dimer Exclusion II, REF 30455-01Class IISep 22, 2021bioMerieux has been receiving an increasing number of compla |
| VIDAS Estradiol II, REF 30431-01Class IISep 22, 2021bioMerieux has been receiving an increasing number of compla |
| VIDAS PRG Progesterone, REF 30409-01Class IISep 22, 2021bioMerieux has been receiving an increasing number of compla |
| VIDAS Lyme IgM II (LYM), REF 416436Class IISep 22, 2021bioMerieux has been receiving an increasing number of compla |
| VIDAS B.R.A.H.M.S. PROCALCITONIN PCT, REF 30450-01Class IISep 22, 2021bioMerieux has been receiving an increasing number of compla |
| ETEST IMIPENEM RELEBACTAM. in vitro diagnosticClass IIJun 24, 2021Major errors (Resistant result instead of Susceptible result |
| VIDAS¿ CMV IgM 30 TestsClass IIMar 16, 2021bioMerieux received complaints about calibration issue obser |
| VITEK 2 Compact (version numbers 8.01, 8.02 (8.0x) and 9.01, 9.02 (9.0x) with the external communication configured to HClass IIJan 28, 2021bioM¿rieux has identified a potential safety risk worst case |
| VITEK 2 (version numbers 8.01, 8.02 (8.0x) and 9.01, 9.02 (9.0x) with the external communication configured to HL7 (systClass IIJan 28, 2021bioM¿rieux has identified a potential safety risk worst case |