BioMérieux VITEK 2 GP System Recall: Atypical Negative Reactions in QC Testing
BioMérieux recalls VITEK 2 GP ID system with specific lot numbers due to atypical negative reactions in Enterococcus casseliflavus QC testing, potentially causing false negative results.
Lower-risk recall
Customer reports have indicated occurrences of atypical negative O129R reactions for Enterococcus casseliflavus ATCC(R) 700327(TM) in association with VITEK(R) 2 GP ID Lot 2420240403 and 2420303403, causing failure of the Quality Control (QC) testing for the VITEK(R) 2 GP ID card. The expected O129R reaction for ATCC¿ 700327(TM) strain is positive.
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What happened, in plain English
BioMérieux is recalling specific lots of their VITEK 2 GP ID system because it has shown atypical negative reactions for Enterococcus casseliflavus in quality control tests. This could lead to false negative results in bacterial identification and antimicrobial susceptibility testing. Read more at govinfonow.com/recall/73114-biom-rieux-vitek-2-gp-system-recall-atypical-negative-reactions.
Source Summary by GovInfoNow · govinfonow.com/recall/73114-biom-rieux-vitek-2-gp-system-recall-atypical-negative-reactions · Updated September 18, 2026 · FDA enforcement record: FDA #Z-3134-2017
Cite this page
“BioMérieux VITEK 2 GP System Recall: Atypical Negative Reactions in QC Testing.” GovInfoNow, updated September 18, 2026. https://govinfonow.com/recall/73114-biom-rieux-vitek-2-gp-system-recall-atypical-negative-reactions. Based on FDA recall #Z-3134-2017 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3134-2017%22&limit=1).
Why it’s dangerous
The system shows atypical negative reactions for Enterococcus casseliflavus in quality control tests, which should normally be positive. This can cause false negative results in bacterial identification and antimicrobial susceptibility testing, potentially leading to incorrect treatment decisions.
Who’s affected
Laboratories using the VITEK 2 GP ID system with lot numbers 2420240403 (expiring July 2018) or 2420303403 (expiring September 2018) are affected. Pathologists and lab technicians who perform bacterial testing are most at risk of inaccurate results.
How to tell if you have this one
Check the lot number on the VITEK 2 GP ID card. Affected lots are 2420240403 (expires July 2018) and 2420303403 (expires September 2018). The product is sold by BioMérieux for laboratory use.
- Brand
BioMérieux- Category
Medical device
What to do — step by step
Check Lot Number
Look for the lot number on the VITEK 2 GP ID card to determine if it is affected (2420240403 or 2420303403).
How this recall unfolded
Recall timeline
FDA terminated this recall 3.2 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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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-3134-2017 (August 25, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-3134-2017 to see it in context.
- Plain-language summary written by qwen3:4b on September 18, 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.