FDA Enforcement
Class II
Ongoing
Revogene C. difficile, in vitro diagnostic assay intended for use with the Revogene instrument, Catalog Number 410300
Recall: Z-1019-2026
·
Reported January 14, 2026
Enforcement
- Recall Number
- Z-1019-2026
- Event ID
- 98038
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Meridian Bioscience Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- January 14, 2026
- Initiation Date
- December 5, 2025
- Classification Date
- January 5, 2026
- Address
- 3471 River Hills Dr, Cincinnati, OH, 45244-3023, United States
Description
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.
Code Info
UDI-DI: 00840733102349; Lot Numbers: 410300U195, 410300U196, 410300U197, 410300U201
Distribution
US Nationwide distribution and the OUS country of Italy.
Quantity
211 units