Biomerieux recalls
Biomerieux appears in 476 official U.S. recall notices indexed by RecallRadar.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
- 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 Device · Class II · 2022-09-07 · Biomerieux - NUCLISENS easyMAG Magnetic Silica, REF 280133, 24 x 1.2mL bottles/kit
FDA Device · Class II · 2022-08-31 · Biomerieux - VITEK 2 Systems and VITEK 2 with MYLA
FDA Device · Class II · 2022-05-18 · Biomerieux - API ID 32 C Strips, Reference 32200, Rx Only, IVD API ID 32 C is a qualitative standardized system for the identification of yeasts
FDA Device · Class II · 2022-02-02 · Biomerieux - VIDAS Measles IgG (MSG), REF 30219
FDA Device · Class II · 2022-01-05 · Biomerieux - VIDAS DEX@, Dimer Exclusion II, REF 30455-01
FDA Device · Class II · 2022-01-05 · Biomerieux - VIDAS TOXO IgG Avidity (TXGA), REF 30222-01
FDA Device · Class II · 2022-01-05 · Biomerieux - VIDAS LH, REF 30406-01
FDA Device · Class II · 2022-01-05 · Biomerieux - RAPID 20 E, REF 20701, System for the identification of Enterobacteriaceae in 4 hours, 25 strips/package, IVD
FDA Device · Class II · 2022-01-05 · Biomerieux - VIDAS Mumps IgG (MPG), REF 30218
FDA Device · Class II · 2022-01-05 · Biomerieux - VIDAS Lyme IgM II (LYM), REF 416436
FDA Device · Class II · 2022-01-05 · Biomerieux - VIDAS B.R.A.H.M.S. PROCALCITONIN PCT, REF 30450-01
FDA Device · Class II · 2022-01-05 · Biomerieux - VIDAS PRG Progesterone, REF 30409-01
FDA Device · Class II · 2022-01-05 · Biomerieux - VIDAS RUB IgG (RBG), REF 30226
FDA Device · Class II · 2022-01-05 · Biomerieux - VIDAS Lyme IgG II (LYM), REF 417401
FDA Device · Class II · 2022-01-05 · Biomerieux - VIDAS Clostridium Difficile GDH, REF 30125-01
FDA Device · Class II · 2022-01-05 · Biomerieux - VIDAS Clostridium Difficile Toxin A&B, CDAB,REF 30118-01
FDA Device · Class II · 2022-01-05 · Biomerieux - VIDAS SARS-COV-2 IgG, Ref 423834-01
FDA Device · Class II · 2022-01-05 · Biomerieux - VIDAS Estradiol II, REF 30431-01
FDA Device · Class II · 2022-01-05 · Biomerieux - VIDAS SARS-COV-2 IgM, Ref 423833-01
FDA Device · Class II · 2022-01-05 · Biomerieux - VIDAS FSH, REF 30407-01
FDA Device · Class II · 2022-01-05 · Biomerieux - API 50 CH, Model 50300
FDA Device · Class II · 2021-11-24 · Biomerieux - MYLA Versions: 4.7, 4.7.1, 4.8, 4.8.1 and 4.8.2, part of the VIRTUO System
FDA Device · Class II · 2021-10-20 · Biomerieux - ETEST IMIPENEM RELEBACTAM. in vitro diagnostic
FDA Device · Class II · 2021-08-18 · Biomerieux - MYLA software
FDA Device · Class II · 2021-08-18 · Biomerieux - VIDAS¿ CMV IgM 30 Tests
FDA Device · Class II · 2021-04-21 · Biomerieux - 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, a…
FDA Device · Class II · 2021-03-31 · Biomerieux - VITEK 2 (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 Device · Class II · 2021-03-31 · Biomerieux - PREVI Isola Insrument and PREVI Isola Printer spares PSUs (power supply units), P1028888-001 PSU (used in Zebra LP2824 Plus printers) PSUs…
FDA Device · Class II · 2020-04-29 · Biomerieux - 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…
FDA Device · Class II · 2020-04-29 · Biomerieux - VITEK 2 card AST-N371 - Product Usage: The VITEK 2 is an automated system consisting of instruments, software, and reagent cards designed f…
FDA Device · Class II · 2020-04-01 · Biomerieux - VIDAS Varicella Zoster IgG (VZG) antibody IVD, kit
FDA Device · Class II · 2020-02-19 · Biomerieux - BIOMERIEUX VIDAS 3, Compact immunoanalyzer with full traceability and automation
FDA Device · Class II · 2020-02-12 · Biomerieux - Biomerieux Vitek 2 Test kit VITEK 2 is an automated system consisting of instruments, software and reagent cards designed for the identific…
FDA Device · Class II · 2019-04-24 · Biomerieux - VITEK 2 AST-N351 Test Kit
FDA Device · Class II · 2019-02-27 · Biomerieux - VITEK¿ 2 Systems Software Version 9.01 Update Kit
FDA Device · Class II · 2018-12-26 · Biomerieux - VITEK 2 Antimicrobial Susceptibility Testing (AST) using one or more of these susceptibility products: Catalog # 410028, VITEK 2 AST-ST01 C…
FDA Device · Class II · 2018-12-26 · Biomerieux - bioM¿rieux NucliSENS easyMAG Lysis Buffer ref. 280134
FDA Device · Class II · 2018-11-21 · Biomerieux - BACT/ALERT VIRTUO system, A Unit China, with Version R2.0 Firmware Product Usage: The BacT/ALERT VIRTU Microbial Detection System is an aut…
FDA Device · Class II · 2018-10-31 · Biomerieux - BACT/ALERT VIRTUO system, B Unit, with Version R2.0 Firmware Product Usage: The BacT/ALERT VIRTU Microbial Detection System is an automated…
FDA Device · Class II · 2018-10-31 · Biomerieux - NucliSENS¿ Magnetic Extraction Reagents
FDA Device · Class II · 2018-10-31 · Biomerieux - BACT/ALERT VIRTUO system, A Unit, with Version R2.0 Firmware Product Usage: The BacT/ALERT VIRTU Microbial Detection System is an automated…
FDA Device · Class II · 2018-10-31 · Biomerieux - VITEK(R) 2 AST-P640, For susceptibility testing of Staphylococcus spp
FDA Device · Class II · 2018-09-26 · Biomerieux - VITEK(R) 2 AST-P655, For susceptibility testing of Staphylococcus spp
FDA Device · Class II · 2018-09-26 · Biomerieux - bioM¿rieux VITEK 2 NH ID Test Kit Product Usage: Is an automated system consisting of instruments, software and reagent cards designed for…
FDA Device · Class II · 2018-08-29 · Biomerieux - bioMerieux VITEK 2 Gram Positive Cefoxitin Screen, VITEK 2 Gram Positive AST for Oxacillin, VITEK SYSTEMS General Susceptibility Card Cefot…
FDA Device · Class I · 2018-08-29 · Biomerieux - VIDAS LH, Reference Numbers 30406 and 30406-01
FDA Device · Class II · 2018-08-08 · Biomerieux - BioMerieux mini VIDAS System in combination with Quality Control VIDAS* (QCV*) Product Usage: the Quality Control VIDAS (QCV) is an automat…
FDA Device · Class II · 2018-07-18 · Biomerieux - BioMerieux VIDAS System in combination with Quality Control VIDAS* (QCV*) Product Usage: the Quality Control VIDAS (QCV) is an automated te…
FDA Device · Class II · 2018-07-18 · Biomerieux - VIDAS FSH, Ref 30407-01, IVD, Rx. The firm name on the label is bioMerieux SA, France
FDA Device · Class II · 2018-07-04 · Biomerieux