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.
The top seal of some of the pouches was compromised which can allow moisture to enter that can impact some antibiotics on the card.
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.
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.
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.
Check for the VITEK 2 AST-N371 card with lot number 0210932204. The product was sold starting in 2021.
Look for the lot number 0210932204 on the VITEK 2 AST-N371 card.
The top seal of some pouches may allow moisture in, which could impact antibiotic test results.
Check the lot number on the card; if it's 0210932204, contact Biomerieux for guidance.
No, this is a low-risk issue affecting test accuracy, not safety.
We’ve drafted a message you can send Biomerieux to request your refund or repair — edit it as you like.
Subject: Recall Z-1534-2020 — Biomerieux Biomerieux Hello, I own a Biomerieux that is covered by recall Z-1534-2020 from Biomerieux. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
