Meridian Bioscience recalls Revogene C. difficile diagnostic assay (Lot 410300U195-201) due to potential false-negative results over time. Affected units may not detect infections correctly.
The affected lots show a decline in performance over time, which may lead to false-negative results.
Meridian Bioscience is recalling specific lots of their Revogene C. difficile test kits because they may give false-negative results over time, meaning infections could go undetected. This is important for healthcare providers using the test to avoid missing infections.
The test kits may show a decline in performance over time, leading to false-negative results. This means the test might fail to detect C. difficile infections when they are actually present, potentially causing undiagnosed infections.
Healthcare providers using the Revogene C. difficile test kits with the specified lot numbers are most at risk. Patients relying on these tests for accurate infection detection could be affected.
Check the lot numbers on the test kit: 410300U195, 410300U196, 410300U197, or 410300U201. These kits were sold with the Revogene instrument and catalog number 410300.
Look for lot numbers 410300U195, 410300U196, 410300U197, or 410300U201 on the test kit.
The affected lots may show a decline in performance over time, which could lead to false-negative results, meaning infections might go undetected.
Check the lot numbers on the test kit. If it matches the recalled lots (410300U195-201), contact Meridian Bioscience for guidance.
The recall record does not mention a remedy or fix for the test kits.
We’ve drafted a message you can send Meridian Bioscience to request your refund or repair — edit it as you like.
Subject: Recall Z-1019-2026 — Meridian Bioscience Meridian Bioscience Hello, I own a Meridian Bioscience that is covered by recall Z-1019-2026 from Meridian Bioscience. 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.
