Biomerieux recalls ETEST Amikacin AK 256 US S3: Temperature/time issues may affect product performance. Learn if you have the affected batch and what to do.
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Biomerieux is recalling ETEST CLINICAL AMIKACIN AK 256 US S30 products because they may not work properly if stored outside the recommended temperature and time range. This could lead to inaccurate test results in clinical settings.
The product may not function correctly if stored outside the specified temperature and time range. This could result in inaccurate test results, potentially affecting clinical decisions.
Healthcare professionals using the ETEST Amikacin AK 256 US S30 products for clinical testing. Patients receiving treatment based on these tests may be at risk if results are inaccurate.
Check for the product name 'ETEST CLINICAL AMIKACIN AK 256 US S30' and catalog number 412218. Affected batches include 1009209480.
Identify the product name, catalog number, and batch number to confirm if it's affected.
The recall states that product performance may not be guaranteed if temperature and time out of range, but it does not indicate immediate danger if used within specifications.
The recall does not specify a remedy, so no action is required beyond checking if you have the affected product.
Look for the product name 'ETEST CLINICAL AMIKACIN AK 256 US S30', catalog number 412218, and batch number 1009209480.
We’ve drafted a message you can send Biomerieux to request your refund or repair — edit it as you like.
Subject: Recall Z-0817-2023 — Biomerieux Biomerieux Hello, I own a Biomerieux that is covered by recall Z-0817-2023 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.
