Device product
Revogene C. difficile, in vitro diagnostic assay intended for use with the Revogene instrument, Catalog Number 410300
Z-1019-2026
Product summary
- Event
- Event 98038
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 211 units
- Official record key
device-enforcement:Z-1019-2026
Official wording
Reason: The affected lots show a decline in performance over time, which may lead to false-negative results.
Code information: UDI-DI: 00840733102349; Lot Numbers: 410300U195, 410300U196, 410300U197, 410300U201
Distribution pattern: US Nationwide distribution and the OUS country of Italy.
Derived failure modes
-
Unknown
The affected lots show a decline in performance over time, which may lead to false-negative results.