bioMerieux recalls VIDAS Clostridium Difficile GDH test kits with substrate error that may cause delayed results. Affected units have UDI 03573026444204 and Lot # 1008686690.
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 Clostridium Difficile GDH test kits due to a substrate error that prevents the test from running, potentially causing delayed results. This affects users who need timely testing for Clostridium difficile infections.
The substrate error prevents the test from running correctly, requiring users to repeat the test. This can delay results, potentially affecting timely diagnosis and treatment of Clostridium difficile infections.
Users of VIDAS Clostridium Difficile GDH test kits with UDI 03573026444204 and Lot # 1008686690 are affected. Healthcare professionals and patients using these tests for Clostridium difficile infections are most at risk.
Check for the UDI 03573026444204 and Lot # 1008686690 on the test kit packaging. The product is sold under the brand bioMerieux.
Look for the UDI 03573026444204 and Lot # 1008686690 on the test kit packaging to confirm if it is affected.
bioMerieux has received complaints about a substrate error that prevents the test from running, leading to potential delayed results.
Check the UDI 03573026444204 and Lot # 1008686690 on the packaging. If affected, contact bioMerieux for guidance.
The recall record does not mention a remedy or fix for the substrate error.
We’ve drafted a message you can send bioMerieux to request your refund or repair — edit it as you like.
Subject: Recall Z-0426-2022 — bioMerieux bioMerieux Hello, I own a bioMerieux that is covered by recall Z-0426-2022 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.
