Biomerieux recalls GENE-UP Lysis Kit (catalog 414057) due to temperature and time issues affecting performance. Affected units include specific batch numbers and UDI/DI codes.
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Biomerieux is recalling its GENE-UP Lysis Kit (catalog 414057) because it may not work properly if stored or used outside the correct temperature and time range. This could lead to unreliable results in laboratory testing.
The kit may not function correctly if stored or used outside the required temperature and time range. This can cause unreliable laboratory results, but does not pose a direct physical danger to users.
Laboratory users who own or use the GENE-UP Lysis Kit with catalog number 414057 and specific batch numbers or UDI/DI codes are affected. Researchers and lab technicians are most at risk of inaccurate test results.
Check for the catalog number 414057 on the kit. Affected units have specific batch numbers (1009334990) and UDI/DI code 3573026387761.
Verify the catalog number 414057 and batch numbers (1009334990) or UDI/DI code 3573026387761 on the kit.
No, the recall is for potential performance issues, not a physical hazard. The kit may not work correctly if stored or used outside the correct temperature and time range.
Check the catalog number and batch numbers on the kit to see if it's affected. If it is, you may need to contact Biomerieux for further instructions.
Look for the catalog number 414057 and specific batch numbers (1009334990) or UDI/DI code 3573026387761 on the kit.
We’ve drafted a message you can send Biomerieux to request your refund or repair — edit it as you like.
Subject: Recall Z-0840-2023 — Biomerieux Biomerieux Hello, I own a Biomerieux that is covered by recall Z-0840-2023 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.
