Biomerieux recalls ETEST Rifampicin RI 32 US S30 (Catalog 412:449) due to potential performance issues from temperature/time exposure. Affected units have specific batch numbers and UDI/DI codes.
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Biomerieux is recalling ETEST Clinical Rifampicin RI 32 US S30 test kits because they may not work properly if stored or used outside recommended temperature and time ranges. This could lead to inaccurate test results if the product is not handled correctly.
The test kits may not function correctly if stored or used outside the manufacturer's specified temperature and time ranges. This can happen if the product is exposed to conditions that cause temperature and time out of range, leading to unreliable test results.
Healthcare professionals and labs using the ETEST Rifampicin RI 32 US S30 test kits with batch numbers starting with 1009190620 are affected. Those handling the product without proper temperature control are at higher risk of inaccurate results.
Check for the product name 'ETEST Clinical Rifampicin RI 32 US S30' with catalog number 412449. Affected units have UDI/DI 03573026378592 and batch numbers starting with 1009190620.
Verify the product name, catalog number, UDI/DI code, and batch numbers to confirm if your item is affected.
The product may not work properly if stored or used outside the manufacturer's recommended temperature and time ranges, which could lead to inaccurate test results.
Check for the product name 'ETEST Clinical Rifampicin RI 32 US S30' with catalog number 412449 and UDI/DI 03573026378592, batch numbers starting with 1009190620.
The recall does not specify a remedy, so you should check the product details to confirm if it's affected and contact Biomerieux for further guidance.
We’ve drafted a message you can send Biomerieux to request your refund or repair — edit it as you like.
Subject: Recall Z-0829-2023 — Biomerieux Biomerieux Hello, I own a Biomerieux that is covered by recall Z-0829-2023 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.
