Biomerieux recalls VITEK MS-CHCA clinical reagents with batch numbers 1009391190, 1009434380, 1009472100 due to potential performance issues from temperature/time out of range.
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Biomerieux is recalling specific batches of VITEK MS-CHCA clinical reagents because they may not perform correctly if stored or used outside recommended temperature and time ranges. This could affect test accuracy in medical labs using these reagents.
The reagents may not function properly if stored or used outside the manufacturer's specified temperature and time ranges. This could lead to unreliable test results in clinical settings, potentially affecting patient care decisions.
Medical labs using the VITEK MS-CHCA reagents with batch numbers 1009391190, 1009434380, or 1009472100 are likely affected. Lab technicians handling these reagents face the highest risk of inaccurate test results.
Check for batch numbers 1009391190, 1009434380, or 1009472100 on the VITEK MS-CHCA reagents. The product is sold under the brand Biomerieux with catalog number 411071.
Look for batch numbers 1009391190, 1009434380, or 1009472100 on the reagent packaging.
The reagents may not perform correctly if stored or used outside the manufacturer's temperature and time ranges, which could lead to inaccurate test results.
Check the batch number on the reagent packaging. If it matches 1009391190, 1009434380, or 1009472100, contact Biomerieux for further instructions.
The recall record does not mention a remedy or fix for this issue.
We’ve drafted a message you can send Biomerieux to request your refund or repair — edit it as you like.
Subject: Recall Z-0815-2023 — Biomerieux Biomerieux Hello, I own a Biomerieux that is covered by recall Z-0815-2023 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.
