FDA Device recall Z-1019-2026
Revogene C. difficile, in vitro diagnostic assay intended for use with the Revogene instrument, Catalog Number 410300
- FDA Device
- Class II
- ongoing
- Published 2026-01-14
On 2026-01-14 the FDA classified a Class II recall of Revogene C. difficile, in vitro diagnostic assay intended for use with the Revogene instrument, Catalog Number 410300 by Meridian Bioscience, citing the affected lots show a decline in performance over time, which may lead to false-negative results.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1019-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-12-05 |
| Published | 2026-01-14 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Meridian Bioscience |
| Distribution | US |
Product
Revogene C. difficile, in vitro diagnostic assay intended for use with the Revogene instrument, Catalog Number 410300
Reason
The affected lots show a decline in performance over time, which may lead to false-negative results.
Identifiers
| code_info | UDI-DI: 00840733102349; Lot Numbers: 410300U195, 410300U196, 410300U197, 410300U201 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1019-2026%22
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