Reported Jan 14, 2026 · Ongoing
Revogene C. difficile, in vitro diagnostic assay intended for use with the Revogene instrument, Catalog Number 410300
Meridian Bioscience Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Meridian Bioscience Inc · 3471 River Hills Dr · Cincinnati, OH · 45244-3023
Is this the product you have?
- Revogene C. difficile, in vitro diagnostic assay intended for use with the Revogene instrument, Catalog Number 410300
- Lot codes and dates
- UDI-DI00840733102349
- Lot Numbers
410300U195410300U196410300U197410300U201
- Amount recalled
- 211 units
Where it was sold
- Nationwide
Why it was recalled
The affected lots show a decline in performance over time, which may lead to false-negative results.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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