Biomerieux Inc
277 recalls on record · Latest: Feb 11, 2026
FDA Devices Moderate Jan 11, 2023
API NIT1 NIT2 REAGENTS, CATALOG 70442
FDA Devices Moderate Jan 11, 2023
BIOBALL A.BRASILIENSIS NCPF 2275 550X20, CATALOG 56011
FDA Devices Moderate Jan 11, 2023
ETEST CLINICAL TOBRAMYCIN TM 256 US S30, CATALOG 412478
FDA Devices Moderate Jan 11, 2023
VITEK 2 REAGENT AST-XN15 TEST KIT 20 CARDS, CATALOG 423829
FDA Devices Moderate Jan 11, 2023
PPM CLINICAL CHROMID STREPTO B US 20 PLT, CATALOG 419751
FDA Devices Moderate Jan 11, 2023
BIOBALL K.RHIZOPHILA (30X20), CATALOG 412690
FDA Devices Moderate Jan 11, 2023
VITEK 2 REAGENT AST-GN70 TEST KIT 20 CARDS, CATALOG 413401
FDA Devices Moderate Jan 11, 2023
ETEST CLINICAL VANCOMYCIN VA 256 US S30, CATALOG 412486
FDA Devices Moderate Jan 11, 2023
VITEK 2 REAGENT BCL TEST KIT VTK2 20 CARDS, CATALOG 21345
FDA Devices Moderate Jan 11, 2023
VITEK MS CLINICAL REAGENT VITEK MS-CHCA, CATALOG 411071
FDA Devices Moderate Jan 11, 2023
PPM CLINICAL CRAPONNE CHROMID C.DIFFICILE 20 PLT, CATALOG 43871
FDA Devices Moderate Jan 11, 2023
ETEST CLINICAL ETEST VANCOMYCIN VA M100 US, CATALOG 423788
FDA Devices Moderate Jan 11, 2023
VITEK 2 REAGENT AST-GP67 TEST KIT 20 CARDS, CATALOG 22226
FDA Devices Moderate Jan 11, 2023
ETEST CLINICAL IMIPENEM RELEBACTAM IPR US S30, CATALOG 420927
FDA Devices Moderate Oct 5, 2022
VIDAS CMV IgM, 30 tests, REF 30205-01, IVD, Rx.
FDA Devices Moderate Sep 7, 2022
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
FDA Devices Moderate Aug 31, 2022
NUCLISENS easyMAG Magnetic Silica, REF 280133, 24 x 1.2mL bottles/kit.
FDA Devices Moderate May 18, 2022
VITEK 2 Systems and VITEK 2 with MYLA.
FDA Devices Moderate Feb 2, 2022
API ID 32 C Strips, Reference 32200, Rx Only, IVD API ID 32 C is a qualitative standardized system for the identification of yeasts. It uses minia…
FDA Devices Moderate Jan 5, 2022
VIDAS RUB IgG (RBG), REF 30226
FDA Devices Moderate Jan 5, 2022
VIDAS FSH, REF 30407-01
FDA Devices Moderate Jan 5, 2022
VIDAS SARS-COV-2 IgM, Ref 423833-01
FDA Devices Moderate Jan 5, 2022
VIDAS TOXO IgG Avidity (TXGA), REF 30222-01
FDA Devices Moderate Jan 5, 2022
VIDAS Estradiol II, REF 30431-01
FDA Devices Moderate Jan 5, 2022
VIDAS Lyme IgG II (LYM), REF 417401
FDA Devices Moderate Jan 5, 2022
VIDAS PRG Progesterone, REF 30409-01
FDA Devices Moderate Jan 5, 2022
VIDAS LH, REF 30406-01
FDA Devices Moderate Jan 5, 2022
VIDAS Measles IgG (MSG), REF 30219
FDA Devices Moderate Jan 5, 2022
VIDAS Clostridium Difficile GDH, REF 30125-01
FDA Devices Moderate Nov 24, 2021
API 50 CH, Model 50300
FDA Devices Moderate Aug 18, 2021
ETEST IMIPENEM RELEBACTAM. in vitro diagnostic
FDA Devices Moderate Apr 21, 2021
VIDAS¿ CMV IgM 30 Tests
FDA Devices Moderate Mar 31, 2021
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, automated, …
FDA Devices Moderate Apr 29, 2020
The VITEK 2 Gram-positive Susceptibility Card is intended for use with the VITEK 2 Systems in clinical laboratories as an in-vitro test to determine …
FDA Devices Moderate Apr 24, 2019
Biomerieux Vitek 2 Test kit VITEK 2 is an automated system consisting of instruments, software and reagent cards designed for the identification …
FDA Devices Moderate Feb 27, 2019
VITEK 2 AST-N351 Test Kit
FDA Devices Moderate Dec 26, 2018
VITEK¿ 2 Systems Software Version 9.01 Update Kit.
FDA Devices Moderate Dec 26, 2018
VITEK 2 Antimicrobial Susceptibility Testing (AST) using one or more of these susceptibility products: Catalog # 410028, VITEK 2 AST-ST01 Catalog #…
FDA Devices Moderate Oct 31, 2018
BACT/ALERT VIRTUO system, B Unit, with Version R2.0 Firmware Product Usage: The BacT/ALERT VIRTU Microbial Detection System is an automated micro…
FDA Devices Moderate Oct 31, 2018
BACT/ALERT VIRTUO system, A Unit China, with Version R2.0 Firmware Product Usage: The BacT/ALERT VIRTU Microbial Detection System is an automated…
FDA Devices Moderate Sep 26, 2018
VITEK(R) 2 AST-P655, For susceptibility testing of Staphylococcus spp. Enterococcus spp., ad S agalactiae against specified antimicrobials, REF 42191…
FDA Devices Moderate Sep 26, 2018
VITEK(R) 2 AST-P640, For susceptibility testing of Staphylococcus spp. Enterococcus spp., ad S agalactiae against specified antimicrobials, REF 41857…
FDA Devices Critical Aug 29, 2018
bioMerieux VITEK 2 Gram Positive Cefoxitin Screen, VITEK 2 Gram Positive AST for Oxacillin, VITEK SYSTEMS General Susceptibility Card Cefotoxin …
FDA Devices Moderate Aug 8, 2018
VIDAS LH, Reference Numbers 30406 and 30406-01. Poduct Usage: VIDAS LH is an automated quantitative test for use on the VIDAS family instruments …
FDA Devices Moderate Jul 18, 2018
BioMerieux VIDAS System in combination with Quality Control VIDAS* (QCV*) Product Usage: the Quality Control VIDAS (QCV) is an automated test for…
FDA Devices Moderate Sep 27, 2017
VITEK(R) 2 GP, REF 21342, IVD, UDI 03573026131920, bioMerieux, Inc. VITEK(R) 2 is an automated system consisting of instruments, software and reagen…
FDA Devices Moderate Sep 6, 2017
VITEK¿ 2 Compact 30, REF numbers: 27530 and 27530R (clinical), and 27630 and 17630R (industry) software and reagent cards designed for the identific…
FDA Devices Moderate Sep 6, 2017
VITEK¿ 2 Compact 15, REF numbers: 27415 and 27415R software and reagent cards designed for the identification (ID) and antimicrobial susceptibility …
FDA Devices Moderate Aug 2, 2017
VITEK 2 Gram Negative test kits containing colistin (cs01n)
FDA Devices Moderate Jul 19, 2017