bioMerie: VIDAS Clostridium Difficile Toxin A&B tests with substrate error may cause delayed results. Recalled lots: 1008730880. Contact for replacement.
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 Toxin A&B tests that may cause delayed results due to a substrate error. This could lead to unnecessary retesting and potential delays in diagnosis.
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 timely treatment decisions.
Healthcare professionals using the VIDAS CDAB tests for Clostridium difficile testing are affected. Those who have the recalled lot numbers are most at risk of delayed results.
Check the lot number on the test kit. The recalled lot number is 1008730880. The product is labeled as VIDAS Clostridium Difficile Toxin A&B, CDAB, REF 30118-01.
Look for the lot number on the test kit, which should be 1008730880 for recalled units.
bioMerieux has received complaints about a substrate error that prevents the test from running, leading to potential delayed results.
Check the lot number on the test kit. If it is 1008730880, contact bioMerieux for a replacement.
No, the hazard is limited to potential delayed results and does not involve physical injury.
We’ve drafted a message you can send bioMerieux to request your refund or repair — edit it as you like.
Subject: Recall Z-0425-2022 — bioMerieux bioMerieux Hello, I own a bioMerieux that is covered by recall Z-0425-2022 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.
