Biomerieux recalls VITEK 2 YST test kits with potential performance issues due to temperature and time exposure. Affected kits may not work correctly if stored or used outside specified conditions.
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Biomerieux is recalling VITEK 2 YST test kits that may not perform correctly if stored or used outside the required temperature and time range. This could lead to inaccurate test results.
The test kits may not function properly if exposed to temperatures or time periods outside the manufacturer's specified range. This can cause the test results to be unreliable or inaccurate.
Laboratories using the VITEK 2 YST test kits with catalog number 21343 are likely affected. Users who store or handle these kits outside the specified temperature and time conditions are at higher risk of inaccurate results.
Check for the catalog number 21343 on the kit packaging. The batch numbers 2432261103 and UDI/DI 03573026131937 are also associated with this recall.
Verify if the test kit has been stored or used outside the manufacturer's temperature and time specifications.
The test kits may not perform correctly if stored or used outside the specified temperature and time range, leading to inaccurate results.
Check if the kit has been stored or used outside the manufacturer's temperature and time specifications. If so, contact Biomerieux for guidance.
Look for the catalog number 21343 on the packaging, or batch numbers 2432261103 and UDI/DI 03573026131937.
We’ve drafted a message you can send Biomerieux to request your refund or repair — edit it as you like.
Subject: Recall Z-0789-2023 — Biomerieux Biomerieux Hello, I own a Biomerieux that is covered by recall Z-0789-2023 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.
