BioMerie: A recall for VIDAS Estradiol II test kits (REF 30431-01) due to substrate errors causing potential delayed results. Affected units have UDI 03573026161637 and Lot #1008757880.
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 Estradiol II test kits (REF 30431-01) because a substrate error can cause test results to be delayed. This means users may need to run the test again, which could lead to delays in diagnosis or treatment.
The test kit has a substrate error that prevents the test from running correctly. This causes users to need to run the test again, potentially delaying results and affecting timely medical decisions.
Users of the VIDAS Estradiol II test kit (REF 30431-01) with UDI 03573026161637 and Lot #1008757880 are affected. Healthcare providers and individuals using the test for hormone level monitoring are most at risk.
Check the test kit for the model number REF 30431-01. Affected units have a unique device identifier (UDI) of 03573026161637 and lot number 1008757880.
Look for the model number REF 30431-01, UDI 03573026161637, and lot number 1008757880 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 kit for the model number REF 30431-01, UDI 03573026161637, and lot number 1008757880. If it matches, contact BioMerieux for guidance.
The test kit may need to be run again, but it does not pose an immediate safety risk. Users should follow the recall instructions to avoid delayed results.
We’ve drafted a message you can send BioMerieux to request your refund or repair — edit it as you like.
Subject: Recall Z-0435-2022 — BioMerieux BioMerieux Hello, I own a BioMerieux that is covered by recall Z-0435-2022 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.
