Biomerieux recalls ASTUTE Electronic Quality Control Device (catalog 400016) due to temperature and time out of range affecting performance. Affected units include specific batch numbers.
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Biomerieux is recalling its ASTUTE Electronic Quality Control Device (catalog 400016) because it may not perform correctly if exposed to temperatures or times outside the specified range. This could lead to inaccurate results in laboratory testing.
The device may not function properly if it is exposed to temperatures or time periods outside the manufacturer's specified range. This could result in inaccurate test results in laboratory settings.
Laboratory users who own or use the ASTUTE Electronic Quality Control Device with batch numbers 21EQC0163I, 21EQC0162I, 21EQC0160I, 21EQC0158I, or 21EQC0174I are most at risk. These units were sold in the U.S. with specific serial numbers.
Check for the batch numbers 21EQC0163I, 21EQC0162I, 21EQC0160I, 21EQC0158I, or 21EQC0174I on the device. The device is labeled as the ASTUTE Electronic Quality Control Device (catalog 400016) and was sold in the U.S.
Verify the batch number on your device to see if it matches the affected numbers: 21EQC0163I, 21EQC0162I, 21EQC0160I, 21EQC0158I, or 21EQC0174I.
The device may not perform correctly if exposed to temperatures or time periods outside the manufacturer's specified range, which could lead to inaccurate test results.
Batch numbers 21EQC0163I, 21EQC0162I, 21EQC0160I, 21EQC0158I, and 21EQC0174I are affected.
Check the batch number on your device; if it matches 21EQC0163I, 21EQC0162I, 21EQC0160I, 21EQC0158I, or 21EQC0174I, it is affected.
We’ve drafted a message you can send Biomerieux to request your refund or repair — edit it as you like.
Subject: Recall Z-0812-2023 — Biomerieux Biomerieux Hello, I own a Biomerieux that is covered by recall Z-0812-2023 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.
