Biomerieux recalls ETEST Erythromycin EM 256 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 Erythromycin EM 256 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.
The test kits may not function correctly if stored outside the required temperature and time range. This could result in inaccurate test results, but does not pose a direct safety hazard.
Lab users and healthcare professionals who handle this specific ETEST kit model. Those using the kit without proper temperature control are most at risk.
Check for the catalog number 412333 and batch numbers starting with 1009157090. The product is sold under the ETEST CLINICAL ERYTHROMYCIN EM 256 US S30 name.
Look for the catalog number 412333 and batch numbers starting with 1009157090 on the kit.
The product may not work correctly if stored outside the recommended temperature and time range, leading to inaccurate test results.
The recall does not specify a remedy, so no action is required beyond checking if you have the affected product.
No, the recall states there is no safety hazard; the issue is only with test accuracy.
We’ve drafted a message you can send Biomerieux to request your refund or repair — edit it as you like.
Subject: Recall Z-0823-2023 — Biomerieux Biomerieux Hello, I own a Biomerieux that is covered by recall Z-0823-2023 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.
