Biomerieux VITEK 2 AST-N371 Card Recall: Moisture Risk to Antibiotic Testing
Biomerieux recalls VITEK 2 AST-N371 reagent cards due to compromised pouch seals risking moisture exposure that could affect antibiotic test results. Affected units include specific lot numbers from 2021.
Lower-risk recall
The top seal of some of the pouches was compromised which can allow moisture to enter that can impact some antibiotics on the card.
Contact the company
What happened, in plain English
Biomerieux is recalling VITEK 2 AST-N371 reagent cards because some pouch seals may allow moisture in, which could impact antibiotic test results. This affects laboratory users who rely on these cards for bacterial testing. Read more at govinfonow.com/recall/65884-biomerieux-vitek-2-ast-n371-card-recall-moisture-risk-to.
Source Summary by GovInfoNow · govinfonow.com/recall/65884-biomerieux-vitek-2-ast-n371-card-recall-moisture-risk-to · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1534-2020
Cite this page
“Biomerieux VITEK 2 AST-N371 Card Recall: Moisture Risk to Antibiotic Testing.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/65884-biomerieux-vitek-2-ast-n371-card-recall-moisture-risk-to. Based on FDA recall #Z-1534-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1534-2020%22&limit=1).
Why it’s dangerous
The top seal of some pouches may let moisture in, which could cause certain antibiotics on the card to become less effective. This might lead to inaccurate test results for bacteria and yeast identification.
Who’s affected
Laboratory users who test bacteria and yeast with the VITEK 2 system are most affected. The risk is low as the moisture issue only impacts test accuracy, not safety.
How to tell if you have this one
Check for the VITEK 2 AST-N371 card with lot number 0210932204. The product was sold starting in 2021.
- Brand
Biomerieux- Category
Medical device
What to do — step by step
Check Card Lot Number
Look for the lot number 0210932204 on the VITEK 2 AST-N371 card.
How this recall unfolded
Recall timeline
FDA terminated this recall 2.7 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-1534-2020 (February 5, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1534-2020 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 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.