Biomerieux recalls ETEST CLINICAL ERTAPENEM ETP 32 US S30 due to potential performance issues from temperature and time out of range. Affected units include specific batch numbers and catalog codes.
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Biomerieux is recalling a specific type of ERTAPENEM test kit because it 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 kit may not perform correctly if stored outside the recommended temperature and time range. This could result in inaccurate test results, but does not pose an immediate safety risk to users.
Healthcare professionals using the ETEST CLINICAL ERTAPENEM ETP 32 US S30 test kit for clinical testing are most at risk. The recall applies to specific batch numbers and catalog codes.
Check for the catalog number 412331 and batch numbers starting with 1009491830 on the product label. The product is sold under the brand name Biomerieux.
Verify the catalog number 412331 and batch numbers starting with 1009491830 on the product label.
No, the recall is due to potential performance issues from temperature and time out of range, not an immediate safety hazard.
The recall does not specify a remedy, so no action is required beyond checking the product details.
Look for the catalog number 412331 and batch numbers starting with 1009491830 on the product label.
We’ve drafted a message you can send Biomerieux to request your refund or repair — edit it as you like.
Subject: Recall Z-0822-2023 — Biomerieux Biomerieux Hello, I own a Biomerieux that is covered by recall Z-0822-2023 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.
