Revogene C — Class II medical device recall Z-1019-2026
Ongoing recall by Meridian Bioscience Inc, reported 2026-01-14, distributed nationwide. The affected lots show a decline in performance over time, which may lead to false-negative results.
| Recall number | Z-1019-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Meridian Bioscience Inc, Cincinnati, OH, United States |
| Recall initiated | 2025-12-05 |
| Classified | 2026-01-05 |
| Reported by FDA | 2026-01-14 |
| Distributed | Nationwide (US) |
| Countries outside the US | IT |
| Quantity | 211 units |
| UPC / GTIN / UDI-DI | 00840733102349 |
| Lot numbers | 410300U195, 410300U196, 410300U197, 410300U201 |
| Model numbers | 410300 |
Product
Revogene C. difficile, in vitro diagnostic assay intended for use with the Revogene instrument, Catalog Number 410300
Reason for recall
The affected lots show a decline in performance over time, which may lead to false-negative results.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1019-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.