PlainRecalls

Biomerieux Inc

277 recalls on record · Latest: Feb 11, 2026

Biomerieux Inc Recall Insight

Biomerieux Inc appears on 277 federal recall records indexed by PlainRecalls, out of 83,949 total recalls tracked across the FDA, CPSC, NHTSA, and USDA FSIS. That represents approximately 0.330% of the federal archive — a data point that is only interpretable alongside production volume, product mix, and decades of operation, because a high recall count alone does not establish fault. Large, diversified firms that sell tens of millions of units across many categories will mechanically accumulate more recall records than small manufacturers, even when their defect rates per unit shipped are comparable or lower. The most recent action on this firm is dated Feb 11, 2026, which is the anchor point for assessing whether enforcement is currently active or historical.

On this page of 50 entries, severity tagging shows 5 critical, 43 moderate, and 2 lower-severity recalls. Affected-unit counts are disclosed on 50 of 50 entries — unit-count disclosure is more common on CPSC and NHTSA actions and less common on FDA drug/device recalls, where lot numbers and distribution scope substitute for absolute totals. The records on this page span 1 distinct product categories, with issuing agencies dominated by FDA Devices (50). The date window on this page runs from Aug 14, 2013 to Jun 21, 2017.

Manufacturer-level browsing is useful when monitoring a single firm for patterns — whether recalls cluster around one product family (suggesting a specific design or supplier issue) or scatter across the firm's entire catalog (which can indicate systemic quality-control problems or deliberate regulator attention). Clicking into each recall reveals the specific hazard, remedy, and distribution scope that together determine whether a consumer is actually at risk. For decisions that depend on being current — deciding whether a product in your home is safe, whether to return a gift, or whether to accept a replacement — always verify the recall number on the issuing agency's site, because federal agencies amend, terminate, and re-scope recalls over time and only the agency's live record reflects the current legal status. This page aggregates what agencies have published publicly and is intended for consumer awareness and research.

FDA Devices Moderate Jun 21, 2017

VITEK¿ 2 Gram Negative Susceptibility card (AST-N223), REF 413110, 20 cards per carton.

FDA Devices Moderate Jun 21, 2017

VITEK¿ 2 Gram Negative Susceptibility card (AST-N235), REF 413170, 20 cards per carton.

FDA Devices Moderate Jun 21, 2017

VITEK¿ 2 Gram Negative Susceptibility card (AST-N276), REF 414286, 20 cards per carton.

FDA Devices Moderate Jun 21, 2017

VITEK¿ 2 Gram Negative Susceptibility card (AST-GN66), REF 413398, 20 cards per carton.

FDA Devices Moderate Jun 21, 2017

VITEK 2 Gram Negative Susceptibility card (AST-GN13), REF 22095, 20 cards per carton.

FDA Devices Moderate Jun 21, 2017

VITEK¿ 2 Gram Positive Susceptibility card (AST-P616), REF 410223, 20 cards per carton.

FDA Devices Moderate Jun 21, 2017

VITEK¿ 2 Gram Negative Susceptibility card (AST-N255), REF 413724, 20 cards per carton.

FDA Devices Moderate Jun 21, 2017

VITEK¿ 2 Gram Negative Susceptibility card (AST-GN69), REF 413400, 20 cards per carton.

FDA Devices Moderate Jun 21, 2017

VITEK¿ 2 Gram Negative Susceptibility card (AST-N322), IVD, REF 418489, 20 cards per carton.

FDA Devices Moderate Jun 21, 2017

VITEK¿ 2 Gram Positive Susceptibility card (AST-GP74), REF 414971, 20 cards per carton.

FDA Devices Moderate Jun 21, 2017

VITEK 2 Gram Positive Susceptibility card (AST-P577), REF 22218, 20 cards per carton.

FDA Devices Moderate Jun 21, 2017

VITEK¿ 2 Gram Negative Susceptibility card (AST-N356), IVD, REF 421352, 20 cards per carton.

FDA Devices Moderate Jun 21, 2017

VITEK 2 Gram Negative Susceptibility card (AST-GN14), REF 22096, 20 cards per carton.

FDA Devices Moderate Jun 21, 2017

VITEK¿ 2 Gram Negative Susceptibility card (AST-GN79), REF 413436, 20 cards per carton.

FDA Devices Moderate Jun 21, 2017

VITEK¿ 2 Gram Positive Susceptibility card (AST-P584), REF 22252, 20 cards per carton.

FDA Devices Moderate Jun 21, 2017

VITEK 2 Gram Negative Susceptibility card (AST-GN16), REF 22139, 20 cards per carton.

FDA Devices Moderate Jun 21, 2017

VITEK¿ 2 Gram Negative Susceptibility card (AST-N358), IVD, REF 421441, 20 cards per carton.

FDA Devices Moderate Jun 21, 2017

VITEK¿ 2 Gram Negative Susceptibility card (AST-XN01), REF 410025, 20 cards per carton.

FDA Devices Moderate Jun 21, 2017

VITEK¿ 2 Gram Positive Susceptibility card (AST-P592), REF 22287, 20 cards per carton.

FDA Devices Moderate Jun 21, 2017

VITEK¿ 2 Gram Negative Susceptibility card (AST-N348), IVD, REF 420856, 20 cards per carton.

FDA Devices Moderate Jun 21, 2017

VITEK¿ 2 Gram Negative Susceptibility card (AST-N311), IVD, REF 416952, 20 cards per carton.

FDA Devices Moderate Jun 21, 2017

VITEK¿ 2 Gram Negative Susceptibility card (AST-N327), IVD, REF 418515, 20 cards per carton.

FDA Devices Moderate Jun 21, 2017

VITEK¿ 2 Gram Negative Susceptibility card (AST-N345), IVD, REF 420580, 20 cards per carton.

FDA Devices Critical May 18, 2016

Vitek 2 Gram Positive Susceptibility Test Cards (AST-P640 REF 418579), 20 cards/kit. Product Usage: The VITEK 2 Gram Positive Susceptibility C…

FDA Devices Critical May 18, 2016

Vitek 2 Gram Positive Susceptibility Test Cards (AST-P645 REF 419602), 20 cards/kit. Product Usage: The VITEK 2 Gram Positive Susceptibility Car…

FDA Devices Critical May 18, 2016

Vitek 2 Gram Positive Susceptibility Test Cards (AST-P639 REF 418662), 20 cards/kit. Product Usage: The VITEK 2 Gram Positive Susceptibility Ca…

FDA Devices Critical May 18, 2016

Vitek 2 Gram Positive Susceptibility Test Cards (AST-P644 REF 418673), 20 cards/kit. Product Usage: The VITEK 2 Gram Positive Susceptibility Car…

FDA Devices Critical May 18, 2016

Vitek 2 Gram Positive Susceptibility Test Cards (AST-P642 REF 418604), 20 cards/kit. Product Usage: The VITEK 2 Gram Positive Susceptibility Car…

FDA Devices Moderate Feb 10, 2016

BacT/ALERT¿ SN, bioM¿rieux, Inc. Product Usage: BacT/ALERT¿ Culture Bottles are used with the BacT/ALERT¿ Microbial Detection System in qualitati…

FDA Devices Moderate Jan 6, 2016

Granada Biphasic Broth The product is a selective medium for the screening and identification of Streptococcus agalactiae in pregnant women using …

FDA Devices Moderate Dec 23, 2015

MYLA CLINIC PATCH 3.2.0 CD Product Usage: MYLA is a computer application (Middleware) based on Web 2.0 technology which: Interfaces between the…

FDA Devices Moderate Dec 23, 2015

MYLA MASTER DVD 3.2 CLI DL380 Product Usage: MYLA is a computer application (Middleware) based on Web 2.0 technology which: Interfaces between …

FDA Devices Moderate Dec 23, 2015

MYLA CLI V3.X TO V4.1 ML350 SERVER Product Usage: MYLA is a computer application (Middleware) based on Web 2.0 technology which: Interfaces bet…

FDA Devices Moderate Dec 23, 2015

MYLA CLI V3.X TO V4.1 DL380 SERVER Product Usage: MYLA is a computer application (Middleware) based on Web 2.0 technology which: Interfaces bet…

FDA Devices Moderate Dec 23, 2015

MYLA CLINIC PATCH 3.3.0 CD Product Usage: MYLA is a computer application (Middleware) based on Web 2.0 technology which: Interfaces between the…

FDA Devices Moderate May 20, 2015

Vitek 2 AST-YS07 REF 414 967, Fungal Susceptibility Card, 20 cards per carton, IVD. Intended for use with the Vitek 2 Systems in clinical labora…

FDA Devices Moderate May 20, 2015

Vitek 2 AST-YS01 REF 22 108, Fungal Susceptibility Card, 20 cards per carton, IVD. Intended for use with the Vitek 2 Systems in clinical laborat…

FDA Devices Low Apr 15, 2015

Vitek 2 AST-P640 REF 418 579 Gram Positive Susceptibility Card, 20 cards per container, IVD. Intended for use with the Vitek 2 Systems in clinica…

FDA Devices Low Apr 15, 2015

Vitek 2 AST-P635 REF 416 911 Gram Positive Susceptibility Card, 20 cards per container, IVD. Intended for use with the Vitek 2 Systems in clinica…

FDA Devices Moderate Mar 19, 2014

bioMerieux PREVI Isola System (General purpose,microbiology, diagnostic Medical Device), (REF 29500/29500R), bioMerieux, Hazelwood, MO.

FDA Devices Moderate Nov 6, 2013

chromID Salmonella Agar, Reference No. 43621. A selective isolation and differentiation medium for the detection of Salmonella in human specimens.

FDA Devices Moderate Aug 14, 2013

bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit, UPDT V2S 6.01 ES. Part number: 414561. Th…

FDA Devices Moderate Aug 14, 2013

bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit, UPDT V2S 6.01ML2. Part number: 414538. Th…

FDA Devices Moderate Aug 14, 2013

bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit, UPDT V2S 6.01 ZH. Part number: 414569. Th…

FDA Devices Moderate Aug 14, 2013

bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit, UPDT V2S 6.01ML1. Part number: 414537. Th…

FDA Devices Moderate Aug 14, 2013

bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit, UPDT V2S 6.01 IT. Part number: 414563. Th…

FDA Devices Moderate Aug 14, 2013

bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit, UPDT V2S 6.01 FR. Part number: 414562. Th…

FDA Devices Moderate Aug 14, 2013

bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit, UPDT V2S 6.01 PT. Part number: 414566. Th…

FDA Devices Moderate Aug 14, 2013

bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit, UPDT V2S 6.01 JA. Part number: 414564. Th…

FDA Devices Moderate Aug 14, 2013

bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit V2S RP5800XPE TO 6.01 WES7. Part number: 6201…

Nearby Manufacturers

Other firms with recall activity tracked in the PlainRecalls index.

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Data Sources

  • Source: FDA + CPSC + NHTSA + USDA FSIS — federal recall filings naming this firm. Verify with FDA, CPSC, NHTSA, or USDA FSIS directly.
  • Source: PlainRecalls Manufacturer Index — firm-level aggregation across all four federal recall feeds