FDA DevicesClass II
Revogene C. difficile, in vitro diagnostic assay intended for use with the Revog...
Published: January 14, 2026Recall ID: Z-1019-2026Category: devicesCountry: US
Reason for Recall / Hazard
The affected lots show a decline in performance over time, which may lead to false-negative results.
Product Description & Identification
Revogene C. difficile, in vitro diagnostic assay intended for use with the Revogene instrument, Catalog Number 410300
Additional Source Details
| Field | Value |
|---|---|
| City | Cincinnati |
| State | OH |
| Event id | 98038 |
| Address 1 | 3471 River Hills Dr |
| Code info | UDI-DI: 00840733102349; Lot Numbers: 410300U195, 410300U196, 410300U197, 410300U201 |
| Postal code | 45244-3023 |
| Report date | 20260114 |
| Product type | Devices |
| Product quantity | 211 units |
| Reason for recall | The affected lots show a decline in performance over time, which may lead to false-negative results. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20251205 |
| Initial firm notification | Letter |
| Center classification date | 20260105 |
Overview
- Recalling FirmMeridian Bioscience Inc
- StatusOngoing
- Risk LevelClass II
- DistributionUS Nationwide distribution and the OUS country of Italy.