Revogene C. difficile, in vitro diagnostic assay intended for use with the Revogene instrument, Catalog Number 410300
| Source | FDA Device Enforcement |
|---|---|
| Category | Medical Device |
| Severity | Medium |
| Status | ongoing |
| Recall date | December 05, 2025 |
| Reported | January 14, 2026 |
| Recalling firm | Meridian Bioscience Inc |
| Country / region | United States OH |
Hazard
The affected lots show a decline in performance over time, which may lead to false-negative results.
Affected products
- Revogene C. difficile, in vitro diagnostic assay intended for use with the Revogene instrument, Catalog Number 410300
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