Biomerieux recalls VIDAS HCG 60 Tests (Catalog 30405-01) due to potential performance issues from temperature and time exposure. Affected units may not function correctly if stored or used outside recommended conditions.
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Biomerieux is recalling VIDAS HCG 60 Tests (Catalog 30405-01) because they might not work properly if stored or used outside the recommended temperature and time range. This could lead to inaccurate test results.
The tests may not function correctly if exposed to temperatures or time conditions outside the manufacturer's specifications. This can cause inaccurate pregnancy test results, but does not pose a direct physical danger.
Pregnancy test users who purchased the VIDAS HCG 60 Tests (Catalog 30405-01) from the manufacturer. Those using the tests without proper temperature and time control are most at risk of inaccurate results.
Check for the product name 'VIDAS CLINICAL VIDAS HCG 60 Tests' and catalog number 30405-01. The batch numbers listed are 1009527770.
Ensure the tests are stored and used within the manufacturer's specified temperature and time range to maintain accuracy.
The tests may not function correctly if stored or used outside the recommended temperature and time range, leading to inaccurate results.
Check if the tests are stored and used within the manufacturer's specified temperature and time range to ensure accuracy. No specific action is required beyond proper handling.
No direct physical safety risks are associated with this recall. The issue is related to potential inaccurate test results due to improper storage or use conditions.
We’ve drafted a message you can send Biomerieux to request your refund or repair — edit it as you like.
Subject: Recall Z-0864-2023 — Biomerieux Biomerieux Hello, I own a Biomerieux that is covered by recall Z-0864-2023 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.
