BioMerie: Recall of VIDAS LH tests due to substrate error causing potential delayed results. Affected units have specific UDI and lot numbers.
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 LH tests with a substrate error that prevents proper testing, leading to potential delayed results. This affects users who need timely diagnostic results.
The substrate error prevents the test from running correctly, requiring users to repeat the test. This can delay results, which is critical for timely medical decisions.
Users of VIDAS LH tests with UDI 03573026156930 and lot number 1008848600 are affected. Those needing timely diagnostic results are most at risk.
Check for UDI 03573026156930 and lot number 1008848600 on the test packaging. The product is sold under the VIDAS LH name.
Look for UDI 03573026156930 and lot number 1008848600 on the test packaging.
BioMerieux has received complaints about a substrate error that prevents the test from running, leading to potential delayed results.
Check the test packaging for UDI 03573026156930 and lot number 1008848600. If it matches, contact BioMerieux for guidance.
The recall record does not mention a fix or remedy; users must check if their test is affected and contact BioMerieux.
We’ve drafted a message you can send BioMerieux to request your refund or repair — edit it as you like.
Subject: Recall Z-0433-2022 — BioMerieux BioMerieux Hello, I own a BioMerieux that is covered by recall Z-0433-2022 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.
