bioMerieux recalls VIDAS SARS-COV-2 IgG tests with substrate error that may cause delayed results. Affected units have specific UDI and lot numbers. 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 SARS-COV-2 IgG tests that have a substrate error preventing proper testing. This could lead to delayed results as users must run another test.
The test substrate has an error that prevents the test from running correctly. This means users must repeat the test, potentially causing delays in getting results.
Users of the VIDAS SARS-COV-2 IgG test with UDI 03573026620745 and lot numbers 1008671430 or 1008763910 are affected. Healthcare providers and labs using these tests are most at risk.
Check for the UDI number 03573026620745 and lot numbers 1008671430 or 1008763910 on the test kit. The product is sold under the VIDAS SARS-COV-2 IgG name.
Look for the UDI number 03573026620745 and lot numbers 1008671430 or 1008763910 on the test kit.
bioMerieux has received complaints about a substrate error that prevents the test from running, leading to potential delayed results.
Check the UDI number and lot numbers on the test kit. If affected, contact bioMerieux for further instructions.
The recall record does not specify a remedy or fix.
We’ve drafted a message you can send bioMerieux to request your refund or repair — edit it as you like.
Subject: Recall Z-0439-2022 — bioMerieux bioMerieux Hello, I own a bioMerieux that is covered by recall Z-0439-2022 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.
