bioMerieux recalls VIDAS SARS-COV-2 IgM test (Ref 423833-01) due to substrate error causing potential delayed results. Affected units have UDI 03573026620738 or Lot #1008710950.
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 recalls a specific SARS-CoV-2 IgM test kit because of a substrate error that prevents proper testing, leading to potential delayed results. This affects users who need timely testing for COVID-19.
The test kit has a substrate error that prevents it from running correctly. This means users must repeat the test, potentially causing delays in getting results for SARS-CoV-2 infection.
Users of the VIDAS SARS-COV-2 IgM test kit (Ref 423833-01) with UDI 03573026620738 or Lot #1008710950 are affected. Healthcare professionals and labs using this test may be at risk of delayed results.
Check for the product name 'VIDAS SARS-COV-2 IgM, Ref 423833-01' with UDI 03573026620738 or Lot #1008710950. This test is sold by bioMerieux Inc.
Look for the UDI 03573026620738 or Lot #1008710950 on the test kit to confirm if it's affected.
bioMerieux has received complaints about a substrate error that prevents the test from running correctly, leading to potential delayed results.
Check the UDI and lot number on the kit. If it matches the affected numbers, you may need to repeat the test for accurate results.
The recall record does not mention a fix or remedy; users must repeat the test if the kit 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-0438-2022 — bioMerieux bioMerieux Hello, I own a bioMerieux that is covered by recall Z-0438-2022 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.
