Class II — Meridian Bioscience Inc
| Recalling firm | MERIDIAN BIOSCIENCE, INC. |
|---|---|
| Registered facility | MERIDIAN BIOSCIENCE, INC. (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | 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. |
| Product | Revogene, Catalog no. 610210. IVD test instrument |
| Quantity | 459 (394 US, 65 OUS) |
| Distribution | Worldwide distribution - US Nationwide and the countries of Australia, Chile, Italy, Qatar, and Switzerland. |
| Initiated | 2022-06-22 |
| Classified | 2022-07-28 |
| Recall number | Z-1479-2022 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Meridian Bioscience Inc (Z-1479-2022).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/90549/
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