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Biomerieux Inc Recalls

264 recalls on record. Search official CPSC, FDA, and USDA datasets for every recall issued for Biomerieux Inc.

264Total Recalls
7Critical
19.5MUnits Affected
Jan 5, 2026Most Recent
All Recalls

Every Biomerieux Inc Recall

Sorted by most recent. Click any recall for full details.

264 recalls
High RiskFDA
Biomerieux Inc
VITEK 2 REAGENT AST-ST02 TEST KIT 20 CARDS, CATALOG 420915
Diagnostic Devices·39 affected·Nov 9, 2022
High RiskFDA
Biomerieux Inc
VITEK 2 REAGENT AST-GN99 TEST KIT 20 CARDS, CATALOG 423102
Diagnostic Devices·187 affected·Nov 9, 2022
High RiskFDA
Biomerieux Inc
API NIT1 NIT2 REAGENTS, CATALOG 70442
Diagnostic Devices·1 affected·Nov 9, 2022
High RiskFDA
Biomerieux Inc
BIOBALL A.BRASILIENSIS NCPF 2275 550X20, CATALOG 56011
Medical Devices·2 affected·Nov 9, 2022
High RiskFDA
Biomerieux Inc
ETEST CLINICAL TOBRAMYCIN TM 256 US S30, CATALOG 412478
Medical Devices·4 affected·Nov 9, 2022
High RiskFDA
Biomerieux Inc
VITEK 2 REAGENT AST-XN15 TEST KIT 20 CARDS, CATALOG 423829
Diagnostic Devices·58 affected·Nov 9, 2022
High RiskFDA
Biomerieux Inc
PPM CLINICAL CHROMID STREPTO B US 20 PLT, CATALOG 419751
Medical Devices·6 affected·Nov 9, 2022
High RiskFDA
Biomerieux Inc
BIOBALL K.RHIZOPHILA (30X20), CATALOG 412690
Medical Devices·2 affected·Nov 9, 2022
High RiskFDA
Biomerieux Inc
VITEK 2 REAGENT AST-GN70 TEST KIT 20 CARDS, CATALOG 413401
Diagnostic Devices·120 affected·Nov 9, 2022
High RiskFDA
Biomerieux Inc
ETEST CLINICAL VANCOMYCIN VA 256 US S30, CATALOG 412486
Medical Devices·7 affected·Nov 9, 2022
High RiskFDA
Biomerieux Inc
VITEK 2 REAGENT BCL TEST KIT VTK2 20 CARDS, CATALOG 21345
Diagnostic Devices·1 affected·Nov 9, 2022
High RiskFDA
Biomerieux Inc
VITEK MS CLINICAL REAGENT VITEK MS-CHCA, CATALOG 411071
Diagnostic Devices·46 affected·Nov 9, 2022
High RiskFDA
Biomerieux Inc
PPM CLINICAL CRAPONNE CHROMID C.DIFFICILE 20 PLT, CATALOG 43871
Medical Devices·1 affected·Nov 9, 2022
High RiskFDA
Biomerieux Inc
ETEST CLINICAL ETEST VANCOMYCIN VA M100 US, CATALOG 423788
Medical Devices·2 affected·Nov 9, 2022
High RiskFDA
Biomerieux, Inc.
NUCLISENS easyMAG Magnetic Silica, REF 280133, 24 x 1.2mL bottles/kit.
Medical Devices·1,301 affected·Jul 20, 2022
High RiskFDA
Biomerieux, Inc.
VITEK 2 / MYLA VITEK 2 Software versions 8.01, 8.02 (veterinary use only), 9.01, 9.02, 9.03 MYLA Software versions V4.8 and V4.9
Medical Devices·0 affected·Jul 13, 2022
High RiskFDA
Biomerieux, Inc.
VITEK 2 Systems and VITEK 2 with MYLA.
Medical Devices·21,757 affected·Mar 29, 2022
High RiskFDA
Biomerieux, Inc.
VIDAS CMV IgM, 30 tests, REF 30205-01, IVD, Rx.
Medical Devices·480 affected·Feb 9, 2022
High RiskFDA
Biomerieux Inc
API ID 32 C Strips, Reference 32200, Rx Only, IVD API ID 32 C is a qualitative standardized system for the identification of yeasts. I...
Medical Devices·462 affected·Dec 20, 2021
High RiskFDA
Biomerieux, Inc.
API 50 CH, Model 50300
Medical Devices·1,382 affected·Sep 30, 2021
High RiskFDA
Biomerieux, Inc.
VIDAS RUB IgG (RBG), REF 30226
Medical Devices·0 affected·Sep 22, 2021
High RiskFDA
Biomerieux, Inc.
VIDAS FSH, REF 30407-01
Medical Devices·0 affected·Sep 22, 2021
High RiskFDA
Biomerieux, Inc.
VIDAS SARS-COV-2 IgM, Ref 423833-01
Medical Devices·0 affected·Sep 22, 2021
High RiskFDA
Biomerieux, Inc.
VIDAS TOXO IgG Avidity (TXGA), REF 30222-01
Medical Devices·0 affected·Sep 22, 2021
High RiskFDA
Biomerieux, Inc.
VIDAS Estradiol II, REF 30431-01
Medical Devices·0 affected·Sep 22, 2021
High RiskFDA
Biomerieux, Inc.
VIDAS Lyme IgG II (LYM), REF 417401
Medical Devices·0 affected·Sep 22, 2021
High RiskFDA
Biomerieux, Inc.
VIDAS PRG Progesterone, REF 30409-01
Medical Devices·1,818 affected·Sep 22, 2021
High RiskFDA
Biomerieux, Inc.
VIDAS LH, REF 30406-01
Medical Devices·0 affected·Sep 22, 2021
High RiskFDA
Biomerieux Inc
ETEST IMIPENEM RELEBACTAM. in vitro diagnostic
Diagnostic Devices·1,431 affected·Jun 24, 2021
High RiskFDA
Biomerieux Inc
VIDAS¿ CMV IgM 30 Tests
Medical Devices·18,705 affected·Mar 16, 2021
High RiskFDA
Biomerieux Inc
VITEK 2 Compact (version numbers 8.01, 8.02 (8.0x) and 9.01, 9.02 (9.0x) with the external communication configured to HL7 (system, test,...
Medical Implants·6,777 affected·Jan 28, 2021
High RiskFDA
Biomerieux Inc
The VITEK 2 Gram-positive Susceptibility Card is intended for use with the VITEK 2 Systems in clinical laboratories as an in-vitro test t...
Medical Devices·1,698 affected·Mar 11, 2020
High RiskFDA
Biomerieux, Inc.
Biomerieux Vitek 2 Test kit VITEK 2 is an automated system consisting of instruments, software and reagent cards designed for the ide...
Diagnostic Devices·10,784 affected·Mar 15, 2019
High RiskFDA
Biomerieux, Inc.
VITEK 2 AST-N351 Test Kit
Diagnostic Devices·30,292 affected·Dec 13, 2018
High RiskFDA
Biomerieux, Inc.
VITEK¿ 2 Systems Software Version 9.01 Update Kit.
Medical Devices·5 affected·Nov 13, 2018
High RiskFDA
Biomerieux, Inc.
VITEK 2 Antimicrobial Susceptibility Testing (AST) using one or more of these susceptibility products: Catalog # 410028, VITEK 2 AST-ST0...
Medical Devices·184,374 affected·Oct 22, 2018
High RiskFDA
Biomerieux, Inc.
VITEK(R) 2 AST-P655, For susceptibility testing of Staphylococcus spp. Enterococcus spp., ad S agalactiae against specified antimicrobial...
Medical Implants·10,919 affected·Aug 13, 2018
High RiskFDA
Biomerieux, Inc.
VITEK(R) 2 AST-P640, For susceptibility testing of Staphylococcus spp. Enterococcus spp., ad S agalactiae against specified antimicrobial...
Medical Implants·2,538 affected·Aug 13, 2018
High RiskFDA
Biomerieux, Inc.
BACT/ALERT VIRTUO system, B Unit, with Version R2.0 Firmware Product Usage: The BacT/ALERT VIRTU Microbial Detection System is an aut...
Medical Devices·151 affected·Jun 27, 2018
High RiskFDA
Biomerieux, Inc.
BACT/ALERT VIRTUO system, A Unit China, with Version R2.0 Firmware Product Usage: The BacT/ALERT VIRTU Microbial Detection System is ...
Medical Devices·8 affected·Jun 27, 2018
High RiskFDA
Biomerieux, Inc.
VIDAS LH, Reference Numbers 30406 and 30406-01. Poduct Usage: VIDAS LH is an automated quantitative test for use on the VIDAS family ...
Diagnostic Devices·5,429 affected·Mar 1, 2018
CriticalFDA
Biomerieux, Inc.
bioMerieux VITEK 2 Gram Positive Cefoxitin Screen, VITEK 2 Gram Positive AST for Oxacillin, VITEK SYSTEMS General Susceptibility Card ...
Diagnostic Devices·13,961,320 affected·Jan 26, 2018
High RiskFDA
Biomerieux, Inc.
BioMerieux VIDAS System in combination with Quality Control VIDAS* (QCV*) Product Usage: the Quality Control VIDAS (QCV) is an automa...
Diagnostic Devices·1,866 affected·Jan 4, 2018
High RiskFDA
Biomerieux Inc
VITEK(R) 2 GP, REF 21342, IVD, UDI 03573026131920, bioMerieux, Inc. VITEK(R) 2 is an automated system consisting of instruments, softwar...
Medical Implants·11,703 affected·Aug 25, 2017
High RiskFDA
Biomerieux Inc
VITEK¿ 2 Compact 30, REF numbers: 27530 and 27530R (clinical), and 27630 and 17630R (industry) software and reagent cards designed for t...
Diagnostic Devices·9,234 affected·Jul 12, 2017
High RiskFDA
Biomerieux Inc
VITEK¿ 2 Compact 15, REF numbers: 27415 and 27415R software and reagent cards designed for the identification (ID) and antimicrobial sus...
Diagnostic Devices·1,866 affected·Jul 12, 2017
High RiskFDA
Biomerieux Inc
VITEK 2 Gram Negative test kits containing colistin (cs01n)
Diagnostic Devices·1,520,000 affected·May 16, 2017
High RiskFDA
Biomerieux, Inc.
VIDAS Testosterone, Ref 30418
Medical Devices·742 affected·May 15, 2017