PlainRecalls

Biomerieux Inc

Compiled from official public sources by the publisher.

422 recalls on record · Latest: Jul 15, 2026

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Agency notice ledger

Federal filing book Biomerieux Inc HEAVY-BOOK · SINGLE-AGENCY

#19 of 14,151 · 422 notices · 0.404% archive

  • BOOK 422 notices
  • RANK #19 of 14,151
  • SHARE 0.404% archive
  • AGENCY FDA Devices (422)
  • CAT medical devices
  • CATS 1 category
  • LATEST Jul 15, 2026
  • PHOTO Olympus Corporation

Nearest notice-volume peer: Olympus Corporation of the Americas (8 notice gap)

Biomerieux Inc accounts for about 0.404% of the 104,423-notice archive on 422 distinct filings — a heavy share signal beside absolute volume. FDA · CPSC · USDA FSIS · NHTSA notice stamps for this firm. Read with this firm → · Dominant category → · Similar-volume firm →

How Biomerieux Inc compares to 14,151 recalling firms

Biomerieux Inc ranks 19th of 14,151 tracked firms by distinct recall-event count. Archive size reflects filing volume, not inherent product danger.

Biomerieux Inc vs all firms by recall-notice count

Where this firm's archive sits among every tracked recalling manufacturer

422 19th of 14151 higher than 14,132 of 14,151 firms

Firms, banded by distinct federal recall-event inventory

Each bar is a band; taller bars hold more firms. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source FDA · CPSC · USDA FSIS · NHTSA federal recall filings · 2026-09-14

Biomerieux Inc in the notice-volume neighbourhood

Distinct federal recall events among this firm and nearest nationwide peers

notices

What this shows Biomerieux Inc holds about 0.404% of archive notices alongside 422 distinct filings.

Source FDA · CPSC · USDA FSIS · NHTSA filings aggregated by PlainRecalls As of September 2026
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 miniaturized tests as well as a specially adapted database. After manual inoculation of the strip, reading can be performed either automatically or manually and the identification is obtained using an identification software.
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 Jan 5, 2022

VIDAS DEX@, Dimer Exclusion II, REF 30455-01
FDA Devices Moderate Jan 5, 2022

VIDAS Lyme IgM II (LYM), REF 416436
FDA Devices Moderate Jan 5, 2022

VIDAS B.R.A.H.M.S. PROCALCITONIN PCT, REF 30450-01
FDA Devices Moderate Jan 5, 2022

VIDAS Mumps IgG (MPG), REF 30218
FDA Devices Moderate Jan 5, 2022

RAPID 20 E, REF 20701, System for the identification of Enterobacteriaceae in 4 hours, 25 strips/package, IVD.
FDA Devices Moderate Jan 5, 2022

VIDAS SARS-COV-2 IgG, Ref 423834-01
FDA Devices Moderate Jan 5, 2022

VIDAS Clostridium Difficile Toxin A&B, CDAB,REF 30118-01
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, antimicrobial susceptibility, short incubation). VITEK 2 is an automated system consisting of instruments, software and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria and yeast. The VITEK 2 utilizes growth-based biochemical patterns to determine identification. The VITEK 2 provides minimal inhibi
FDA Devices Moderate Mar 31, 2021

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, antimicrobial susceptibility, short incubation). VITEK 2 is an automated system consisting of instruments, software and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria and yeast. The VITEK 2 utilizes growth-based biochemical patterns to determine identification. The VITEK 2 provides minimal inhibitory con
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 susceptibility of Staphylococcus spp., Enterococcus spp., and S. agalactiae to antimicrobial agents when used as instructed.
FDA Devices Moderate Apr 29, 2020

PREVI Isola Insrument and PREVI Isola Printer spares PSUs (power supply units), P1028888-001 PSU (used in Zebra LP2824 Plus printers) PSUs with the following date code; 0639XX through 1253XX (YYWWXX, where YY=Year, and WW=week).
FDA Devices Moderate Apr 1, 2020

VITEK 2 card AST-N371 - Product Usage: The VITEK 2 is an automated system consisting of instruments, software, and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria and yeast. The VITEK 2 utilizes growth-based biochemical patterns to determine identification. The VITEK 2 provides minimal inhibitory concentration (MIC) results for most organism/drug combinations as well as a category interpretation (S, I, or R) consistent with accepted criteria.
FDA Devices Moderate Feb 19, 2020

VIDAS Varicella Zoster IgG (VZG) antibody IVD, kit
FDA Devices Moderate Feb 12, 2020

BIOMERIEUX VIDAS 3, Compact immunoanalyzer with full traceability and automation
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 and antimicrobial susceptibility testing of bacteria and yeast.
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 # 420915, VITEK 2 AST-ST02 Catalog # 421040, VITEK 2 AST-ST03 The VITEK 2 Streptococcus Susceptibility Card is intended for use with the VITEK 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of S. pneumoniae, beta-hemolytic Streptococcus, and Viridans Streptococcus to antimicrobial agents when used as ins
FDA Devices Moderate Nov 21, 2018

bioM¿rieux NucliSENS easyMAG Lysis Buffer ref. 280134
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 microbial test system capable of incubating, agitating, and continuously monitoring for the detection of aerobic, facultative, and anaerobic microorganism growth from blood and other normally sterile body fluids.
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 microbial test system capable of incubating, agitating, and continuously monitoring for the detection of aerobic, facultative, and anaerobic microorganism growth from blood and other normally sterile body fluids.
FDA Devices Moderate Oct 31, 2018

BACT/ALERT VIRTUO system, A Unit, with Version R2.0 Firmware Product Usage: The BacT/ALERT VIRTU Microbial Detection System is an automated microbial test system capable of incubating, agitating, and continuously monitoring for the detection of aerobic, facultative, and anaerobic microorganism growth from blood and other normally sterile body fluids.
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 421913 Product Usage: VITEK¿ 2 is an automated system consisting of instruments, software and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria and yeast. The VITEK¿ 2 utilizes growth-based biochemical patterns to determine identification. The VITEK¿ 2 provides minimal inhibitory concentration (MIC) r
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 418579 Product Usage: VITEK¿ 2 is an automated system consisting of instruments, software and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria and yeast. The VITEK¿ 2 utilizes growth-based biochemical patterns to determine identification. The VITEK¿ 2 provides minimal inhibitory concentration (MIC) r
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 and AST for Oxacillin bioMerieux VITEK 2 AST-P631 bioMerieux VITEK 2 AST-GP67 Test Kit bioMerieux VITEK 2 AST-GP71 Test Kit bioMerieux VITEK 2 AST-GP75 Test Kit bioMerieux VITEK 2 AST-GP78 Test Kit Components for an automated invitro diagnostic system consisting of instruments, software and reagent cards designed for the ID and antimicro
FDA Devices Moderate Aug 29, 2018

bioM¿rieux VITEK 2 NH ID Test Kit Product Usage: Is an automated system consisting of instruments, software and reagent cards designed for the ID and antimicrobial susceptibility testing of bacteria and yeast.
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 for the determination of human luteinizing hormone in human serum or plasma (lithium heparin), using the ELFA technique (Enzyme Linked Fluorescent Assay)
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 use on the VIDAS¿ system to detect abnormal operation of the VIDAS and mini VIDAS instrument pipette mechanisms and optical systems. Specifically the mini VIDAS system is an immunodiagnostic system intended to be used by trained and qualified laboratory professionals, for In vitro Diagnostic (IVD) purpose, veterinary and industrial applications. Th
FDA Devices Moderate Jul 18, 2018

BioMerieux mini VIDAS System in combination with Quality Control VIDAS* (QCV*) Product Usage: the Quality Control VIDAS (QCV) is an automated test for use on the VIDAS¿ system to detect abnormal operation of the VIDAS and mini VIDAS instrument pipette mechanisms and optical systems. Specifically the mini VIDAS system is an immunodiagnostic system intended to be used by trained and qualified laboratory professionals, for In vitro Diagnostic (IVD) purpose, veterinary and industrial application
FDA Devices Moderate Nov 15, 2017

VITEK2 GP-ID, REF 21342 IVD
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 reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria and yeast. The VITEK¿ 2 utilizes growth based biochemical patterns to determine identification. The VITEK¿ 2 provides minimal inhibitory concentration (MIC) results for most organism/drug combinations as well as a category interpretation (S, I, or R) consist
FDA Devices Moderate Sep 20, 2017

eMAG System, Ref 418591 It is an In Vitro Diagnostic Medical device intended for the automated isolation (purification and concentration) of total nucleic acids (RNA/DNA) from biological specimens, with liquid and homogeneous properties (as part of their natural characteristics or after pre-treatment).
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 identification (ID) and antimicrobial susceptibility testing (AST) of bacteria and yeast.

Biomerieux Inc carries an outsized archive share

Drug and device firms outside this manufacturer and state, matched by notice volume and category footprint.

Similar medical devices volume

Nearest multi-notice firms in the same narrow category lane.

Olympus Corporation of the Americas 414 Baxter Healthcare Corporation 413 Philips North America Llc 404 B Braun Medical Inc 444

Frequently Asked Questions

How many federal recall notices name Biomerieux Inc? ▼
PlainRecalls indexes 422 distinct federal recall events naming Biomerieux Inc, aggregated from FDA, CPSC, USDA FSIS, and NHTSA filings (archive as of September 2026). That count is an issuance inventory, not a hazard score.
Where does Biomerieux Inc sit among other recalling firms? ▼
Biomerieux Inc ranks #19 of 14,151 by distinct recall-event count among 14,151 firms in this archive (99th percentile of firms with fewer notices). Rank tracks filing frequency, not product danger.
Which agency issues most of Biomerieux Inc's notices? ▼
FDA Devices accounts for 422 of this firm's 422 indexed notices.
What product category dominates Biomerieux Inc's filing book? ▼
Filings for Biomerieux Inc span 1 product category, led by medical devices. Browse that category archive for peer firms and related notices.
Is a higher notice count more dangerous? ▼
No. Archive size reflects how often federal agencies publish recalls naming the firm — reporting volume, coverage, and product range all move the number. Always verify the individual notice with the issuing agency before acting on a specific product.
Biomerieux Inc: 422 federal recall notices aggregated from FDA, CPSC, USDA FSIS, and NHTSA filings (lead agency FDA Devices). Verify individual notices with FDA directly before acting on a specific recall.

Firm-level totals aggregate distinct federal recall events naming Biomerieux Inc; individual notices remain authoritative on each linked recall page.

Methodology · Corrections · FDA · CPSC · USDA FSIS · NHTSA · Archive as of September 2026