Revogene C. difficile recall (Meridian Bioscience Inc)
Medical deviceClass IIOngoing
Summary: Meridian Bioscience Inc is recalling Revogene C. difficile, in vitro diagnostic assay intended for use with the Revogene instrument, Catalog Number 410300. Reason: The affected lots show a decline in performance over time, which may lead to false-negative results.
What is being recalled
Revogene C. difficile, in vitro diagnostic assay intended for use with the Revogene instrument, Catalog Number 410300
Why
The affected lots show a decline in performance over time, which may lead to false-negative results.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
US Nationwide distribution and the OUS country of Italy.
How to tell if yours is affected
UDI-DI: 00840733102349; Lot Numbers: 410300U195, 410300U196, 410300U197, 410300U201
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-1019-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | December 5, 2025 |
| Reported | January 14, 2026 |
| Company | Meridian Bioscience Inc |
| Company location | Cincinnati, OH, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 211 units |
More recalls from Meridian Bioscience Inc · all medical device recalls · recalls from December 2025