Z-1019-2026 Class II Ongoing
FDA device recall Z-1019-2026 was initiated by Meridian Bioscience Inc on December 5, 2025 and is designated Class II. Reason for recall: The affected lots show a decline in performance over time, which may lead to false-negative results. The recall status is ongoing. Affected quantity: 211 units.
Recall Details
- Product Type
- Devices
- Report Date
- January 14, 2026
- Initiation Date
- December 5, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 211 units
Product Description
Revogene C. difficile, in vitro diagnostic assay intended for use with the Revogene instrument, Catalog Number 410300
Reason for Recall
The affected lots show a decline in performance over time, which may lead to false-negative results.
Distribution Pattern
US Nationwide distribution and the OUS country of Italy.
Code Information
UDI-DI: 00840733102349; Lot Numbers: 410300U195, 410300U196, 410300U197, 410300U201