Meridian Bioscience Revogene C. difficile Test Recall: False-Negative Risk
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.
Lower-risk recall
The affected lots show a decline in performance over time, which may lead to false-negative results.
Contact the company
What happened, in plain English
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. Read more at govinfonow.com/recall/50519-meridian-bioscience-revogene-c-difficile-test-recall-false-negative-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/50519-meridian-bioscience-revogene-c-difficile-test-recall-false-negative-risk · Updated August 17, 2026 · FDA enforcement record: FDA #Z-1019-2026
Cite this page
“Meridian Bioscience Revogene C. difficile Test Recall: False-Negative Risk.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/50519-meridian-bioscience-revogene-c-difficile-test-recall-false-negative-risk. Based on FDA recall #Z-1019-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1019-2026%22&limit=1).
Why it’s dangerous
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.
Who’s affected
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.
How to tell if you have this one
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.
- Brand
Meridian Bioscience- Category
Medical device
What to do — step by step
Check Lot Numbers
Look for lot numbers 410300U195, 410300U196, 410300U197, or 410300U201 on the test kit.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA distribution: “US Nationwide distribution and the OUS country of Italy.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 40 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
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.
- Official source: FDA Recall #Z-1019-2026 (December 5, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1019-2026 to see it in context.
- Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.