Revogene — Class II medical device recall Z-1479-2022
Ongoing recall by Meridian Bioscience Inc, reported 2022-08-03, distributed nationwide. When a run is aborted, the cooling period protection does not occur and the user is able to open the lid prior
| Recall number | Z-1479-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Meridian Bioscience Inc, Cincinnati, OH, United States |
| Recall initiated | 2022-06-22 |
| Classified | 2022-07-28 |
| Reported by FDA | 2022-08-03 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CH, CL, IT, QA |
| UPC / GTIN / UDI-DI | 00840733102318 |
| Serial numbers | 231151, 231153, 231155, 231160, 231162, 231165, 231166, 231167, 231170, 231172, 231175, 231179, 231180, 231188, 231202, 231205, 231213, 231220, 231221, 231223, 231224, 231227, 231228, 231229, 231231 and 434 more |
| Model numbers | 610210 |
Product
Revogene, Catalog no. 610210. IVD test instrument
Reason for recall
When a run is aborted, the cooling period protection does not occur and the user is able to open the lid prior to the completion of the cooling period, exposing the user to heated instrument components. Incidental contact with heated instrument components may result in an injury such as minor burns.
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-1479-2022. 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.