Revogene C. Difficile, In Vitro Diagnostic Assay Intended For Use With The Revogene Instrument, Catalog Number 410300
Meridian Bioscience is recalling certain lots of the Revogene C. difficile test kit used with the Revogene instrument because the test's performance degrades over time, potentially producing false-negative results that fail to detect C. difficile infections. This affects healthcare facilities and laboratories using the Catalog Number 410300 kit from the affected lots. The FDA classified this as a Class II recall.
- Recalling firm
- Meridian Bioscience Inc
- Product
- 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.
- Classification
- Class II
- Category
- consumer product recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2025-12-05
- Status
- Open, Classified
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/641feb37-401b-46f7-acfe-e155c1b03067