FDAHealthDecember 5, 2025
Meridian Bioscience Inc — Revogene C. difficile, in vitro diagnostic assay intended for use with the Revogene instrument, Catalog Number 410300
⚠️ The affected lots show a decline in performance over time, which may lead to false-negative results.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- December 5, 2025
US Nationwide distribution and the OUS country of Italy.
What's affected?
- Product
- Revogene C. difficile, in vitro diagnostic assay intended for use with the Revogene instrument, Catalog Number 410300
- Lot code
- 410300U195
Additional details
UDI-DI: 00840733102349; Lot Numbers: 410300U195, 410300U196, 410300U197, 410300U201
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 211 units.
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