Biomerieux recalls ETEST CLINICAL IMIPENEM IP 32 US S30 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 ETEST CLINICAL IMIPENEM IP 32 US S30 test kits because they may not work properly if stored outside the recommended temperature and time range. This could lead to inaccurate test results if used incorrectly.
The test kits may not function correctly if stored outside the required temperature and time range. This could cause inaccurate test results, but does not pose a direct physical risk to users.
Healthcare professionals and labs using this specific test kit model are most likely affected. The risk is low as the issue relates to proper storage conditions rather than immediate safety hazards.
Check for the catalog number 412373 and batch numbers starting with 1009371780 on the product label. This specific model was sold with the UDI/DI 03573026377953.
Verify the catalog number 412373 and batch numbers starting with 1009371780 on the product label.
The test kits may not work properly if stored outside the recommended temperature and time range, which could lead to inaccurate results.
Check the product label for the catalog number 412373 and batch numbers starting with 1009371780. If you have these, contact Biomerieux for further instructions.
No, the recall is for potential inaccurate test results due to storage conditions, not a physical safety hazard.
We’ve drafted a message you can send Biomerieux to request your refund or repair — edit it as you like.
Subject: Recall Z-0825-2023 — Biomerieux Biomerieux Hello, I own a Biomerieux that is covered by recall Z-0825-2023 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.
