BioMerie: VIDAS FSH tests with REF 30407-01 may have substrate errors causing delayed results. Affected units include UDI 03573026156947, Lot 1008781470. Contact for remedy.
bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate error. It prevents the test from being run, therefore leads to potential delayed results as the user must run another test.
BioMerieux is recalling VIDAS FSH tests with REF 30407-01 due to a substrate error that prevents tests from running, leading to potential delayed results. This affects users who need timely testing and may require repeating tests.
The substrate error prevents the test from running correctly, requiring users to repeat the test. This can cause delays in getting results, which may impact medical decisions if timely testing is critical.
Users of VIDAS FSH tests with REF 30407-01, particularly those needing timely hormone testing. Laboratory staff and healthcare providers are most at risk of delayed results.
Check for the product name 'VIDAS FSH', reference number 'REF 30407-01', and unique identifier UDI 03573026156947 or lot number 1008781470.
Identify the product name, reference number, and unique identifier to confirm if your test is affected.
BioMerieux has received complaints about a substrate error that prevents the test from running, leading to potential delayed results.
Check the product details to see if it's affected; if so, contact BioMerieux for guidance on next steps.
The error prevents the test from running correctly, requiring users to repeat the test, which can delay results.
We’ve drafted a message you can send BioMerieux to request your refund or repair — edit it as you like.
Subject: Recall Z-0434-2022 — BioMerieux BioMerieux Hello, I own a BioMerieux that is covered by recall Z-0434-2022 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.
