Biomerieux recalls Chemchrome V14 reagents (Catalog 306-R1026-01) due to potential performance issues from temperature and time out of range. 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 Chemchrome V14 reagents (6x1.8ml) because they may not work properly if stored or used outside recommended temperature and time ranges. This could affect test accuracy in medical settings.
The reagents may not perform correctly if stored or used outside the manufacturer's specified temperature and time ranges. This could lead to inaccurate test results in medical diagnostics.
Users of these reagents in medical testing labs or clinics are likely affected. Those handling the reagents without proper temperature control face the highest risk.
Check for the catalog number 306-R1026-01 on the reagent packaging. Affected units have UDI/DI code 03661901000857 and batch numbers starting with 3073090.
Look for the catalog number 306-R1026-01 and UDI/DI code 03661901000857 on the reagent packaging.
The reagents may not perform correctly if stored or used outside the manufacturer's specified temperature and time ranges.
Check the product details to see if it matches the affected units. If it does, contact Biomerieux for guidance.
The recall is for potential performance issues, not safety hazards. There is no risk of injury from normal use.
We’ve drafted a message you can send Biomerieux to request your refund or repair — edit it as you like.
Subject: Recall Z-0869-2023 — Biomerieux Biomerieux Hello, I own a Biomerieux that is covered by recall Z-0869-2023 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.
