Recall Z-1019-2026 ยท OZN C. Difficile Toxin Gene Amplification Assay
Meridian Bioscience Inc
Revogene C. difficile, in vitro diagnostic assay intended for use with the Revogene instrument, Catalog Number 410300
| Date | Jan 5, 2026 (initiated Dec 5, 2025) |
| Status | Open, Classified |
| Reason | The affected lots show a decline in performance over time, which may lead to false-negative results. |
| Root cause | Under Investigation by firm |
| Action | An "URGENT MEDICAL DEVICE CORRECTION" dated 12/1/25 was sent to customers. Required Actions: " Identify and segregate any remaining inventory of impacted product lots and suspend further use. " Destroy remaining inventory of impacted product lot in accordance with state, local, and/or federal regulations. o Contact Technical Service for replacement product. " Review previously obtained results from Revogene C. difficile listed Lots numbers. Any negative results obtained should be re-evaluated in conjunction with presented clinical findings to determine if retesting is required. " Complete and |
| Quantity | 211 units |
| Distribution | US Nationwide distribution and the OUS country of Italy. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K172569 | GenePOC CDiff Genepoc, Inc., Nov 22, 2017 |