Biomerieux recalls VIDAS Listeria 60T test kits due to potential performance issues from temperature and time exposure. Affected units have specific batch numbers and catalog codes.
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Biomerieux is recalling VIDAS Listeria 60T test kits because they may not work properly if exposed to temperatures or times outside the required range. This could lead to inaccurate test results, which is important for medical testing.
The test kits may not function correctly if stored or used outside the specified temperature and time range. This could cause inaccurate results when testing for listeria bacteria, which is critical in clinical settings.
Laboratory users who own or use the VIDAS Listeria 60T test kits with catalog number 30700 and specific batch numbers. Those testing for listeria in clinical settings are most at risk of inaccurate results.
Check for the catalog number 30700 and batch numbers starting with 1009371140 on the product label. The unique device identifier (UDI/DI) 03573026065850 is also associated with these units.
Look for the catalog number 30700 and batch numbers starting with 1009371140 on the product label.
The product may not work correctly if exposed to temperatures or times outside the required range, which could lead to inaccurate test results.
Check the product label for the catalog number 30700 and batch numbers starting with 1009371140. If you have these, contact Biomerieux for further instructions.
The recall record does not mention any 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-0798-2023 — Biomerieux Biomerieux Hello, I own a Biomerieux that is covered by recall Z-0798-2023 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.
