Biomerieux recalls VITEK MS-FA clinical reagents due to temperature and time out of range affecting performance. Affected units include specific catalog and batch numbers.
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Biomerieux is recalling VITEK MS-FA clinical reagents because they may not work properly if stored or used outside recommended temperature and time ranges. This could lead to inaccurate test results in medical settings.
The reagent may not perform correctly if stored or used outside the specified temperature and time ranges. This can cause inaccurate test results, potentially affecting medical diagnoses.
Healthcare facilities using the VITEK MS-FA reagent with catalog number 411072 and batch numbers starting with 1009346190 are most affected. Patients relying on these tests for accurate diagnostics may be impacted.
Check for the catalog number 411072 and batch numbers starting with 1009346190 on the reagent packaging. The unique device identifier (UDI/DI) 03573026362843 is also associated with this recall.
Look for the catalog number 411072 and batch numbers starting with 1009346190 on the reagent packaging.
The reagent may not perform correctly if stored or used outside the specified temperature and time ranges, which can lead to inaccurate test results.
Check the packaging for the catalog number 411072 and batch numbers starting with 1009346190. If you have these, contact Biomerieux for guidance.
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-0816-2023 — Biomerieux Biomerieux Hello, I own a Biomerieux that is covered by recall Z-0816-2023 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.
