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Meridian Bioscience Inc recalls Revogene, Catalog no. 610210. IVD test instrument
Recalled August 3, 2022 · FDA recall Z-1479-2022 · Meridian Bioscience
Hazard
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. · FDA Class II
Units
459 (394 US, 65 OUS)
Sold at
Worldwide distribution - US Nationwide and the countries of Australia, Chile, Italy, Qatar, and Switzerland.
Description
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
Manufacturer(s)
Meridian Bioscience Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →