Lower risk Medical device recall · FDA · Published October 11, 2017

Biomerieux VITEK2 GP-ID Recall: Atypical Negative Reactions for Enterococcus

Biomerieux recalls VITEK2 GP-ID ID cards due to atypical negative reactions for Enterococcus casseliflavus, risking false negative QC test results. Affected lots include specific UDI and lot numbers.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0074-2018Medical device Biomerieux ›

Lower-risk recall

Customers have reported, and an internal investigation has confirmed, occurrences of atypical negative O129R reactions for Enterococcus casseliflavus ATCC)R) 700327(TM) in association with three (3) VITEK(R) 2 GP ID Lots, causing failure of the Quality Control (QC) testing for the VITEK(R) 2 GP ID card. In accordance with the VITEK(R) 2 GP ID Instructions For Use, the expected O129R reaction for ATCC(R) 700327(TM) strain is positive. As a precaution, bioM¿rieux is also including in the scope of this notice all GP ID card lots manufactured with the same raw materials.

Take action

Contact the company

Recalling firmBiomerieux Inc595 Anglum Rd · Hazelwood, MO 63042-2320

✎ GovInfoNow plain-language explainer

Biomerieux is recalling VITEK2 GP-ID ID cards that may show false negative reactions for Enterococcus casseliflavus, which could lead to inaccurate test results. This affects specific lots and requires attention to ensure accurate diagnostic testing. Read more at govinfonow.com/recall/72871-biomerieux-vitek2-gp-id-recall-atypical-negative-reactions-for-enterococcus.

Source Summary by GovInfoNow · govinfonow.com/recall/72871-biomerieux-vitek2-gp-id-recall-atypical-negative-reactions-for-enterococcus · Updated September 14, 2026 · FDA enforcement record: FDA #Z-0074-2018

Cite this page

“Biomerieux VITEK2 GP-ID Recall: Atypical Negative Reactions for Enterococcus.” GovInfoNow, updated September 14, 2026. https://govinfonow.com/recall/72871-biomerieux-vitek2-gp-id-recall-atypical-negative-reactions-for-enterococcus. Based on FDA recall #Z-0074-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0074-2018%22&limit=1).

The FDA announced on 2017-10-11 that Biomerieux Inc is recalling VITEK2 GP-ID IVD devices due to quality control testing failures. The hazard involves atypical negative O129R reactions for Enterococcus casseliflavus ATCC 700327, causing QC failure in association with three specific lots.

How to tell if you have it

Brand: Biomerieux
Product: VITEK2 GP-ID, REF 21342 IVD
UDI: 03573026131920
Lot Number: 2420348103

The hazard

Customers have reported, and an internal investigation has confirmed, occurrences of atypical negative O129R reactions for Enterococcus casseliflavus ATCC 700327 in association with three VITEK 2 GP ID lots. This causes failure of the Quality Control (QC) testing for the VITEK 2 GP ID card. The expected O129R reaction for the ATCC 700327 strain is positive according to the Instructions For Use.

Context

GovInfoNow's records show Biomerieux Inc has 36 other recalls on record since 2017-07-12. Other recent recalls of similar products include Biomerieux VITEK 2 AST-N461 Test Kit Recall (2026-07-24), Biomerieux VITEK 2 AST-N447 Kit Recall (2026-06-04), and Biomerieux VITEK 2 Gram-negative Susceptibility Cards May Give False Antibiotic Results (2026-01-05). Other recent recalls of similar products include Meridian Bioscience Revogene C. difficile Test Recall (2025-12-05), HardyDisk AST Cefiderocol 30μg FDC30 (2026-06-08), and BioFire Joint Infection Panel Recall (2026-04-22).

How to tell if you have this one

Check for the UDI 03573026131920 and Lot Number 2420348103 on the VITEK2 GP-ID ID card. The recall covers all lots manufactured with the same raw materials as these specific lots.

Brand
Biomerieux
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Card Lot Number
Look for the lot number 2420348103 on the VITEK2 GP-ID ID card.

How this recall unfolded

Recall timeline

FDA terminated this recall 3.1 years after the firm started it.

Oct 11, 2017Firm started the recall
Nov 8, 2017FDA classified it Class II
Nov 15, 2017Published in FDA’s Enforcement Report
Nov 9, 2020FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/72871-biomerieux-vitek2-gp-id-recall-atypical-negative-reactions-for-enterococcus">Biomerieux VITEK2 GP-ID Recall: Atypical Negative Reactions for Enterococcus (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-0074-2018 (October 11, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0074-2018 to see it in context.
Plain-language summary written by qwen3:4b on September 14, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.