FDA Medical devices recall ·
Revogene C. difficile, in vitro diagnostic assay intended for use with the… recall
- Recall number
- Z-1019-2026
- Date
- (initiated December 5, 2025)
- Company / brand
- Meridian Bioscience Inc
3471 River Hills Dr, Cincinnati, OH, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 211 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Revogene C. difficile, in vitro diagnostic assay intended for use with the Revogene instrument, Catalog Number 410300
Why was it recalled?
The affected lots show a decline in performance over time, which may lead to false-negative results.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
UDI-DI: 00840733102349; Lot Numbers: 410300U195, 410300U196, 410300U197, 410300U201
Distribution
US Nationwide distribution and the OUS country of Italy.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1019-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.