Biomerieux recalls ETEST CEFTAZIDIM/AVIBACTAM US S30 (Catalog 419046) due to temperature and time issues affecting product performance. No remedy specified in recall notice.
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Biomerieux is recalling ETEST CEFTAZID:IM/AVIBACTAM 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 specified temperature and time range. This could result in inaccurate test results, but does not cause physical harm to users.
Healthcare professionals and labs using the ETEST CEFTAZIDIM/AVIBACTAM US S30 test kits with batch numbers 1009384490 are affected. The risk is low for most users as the issue relates to storage conditions rather than immediate harm.
Check for the product name 'ETEST CEFTAZIDIM/AVIBACTAM US S30' with catalog number 419046 and batch number 1009384490. The recall covers specific batches sold in the U.S.
Identify the catalog number 419046 and batch number 1009384490 to confirm if your kit is affected.
The recall notice does not specify a remedy for this issue.
Check for the catalog number 419046 and batch number 1009384490 on the product label.
No immediate action is required; the issue relates to storage conditions, not immediate harm.
We’ve drafted a message you can send Biomerieux to request your refund or repair — edit it as you like.
Subject: Recall Z-0846-2023 — Biomerieux Biomerieux Hello, I own a Biomerieux that is covered by recall Z-0846-2023 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.
