FDA-Device2022-08-03Class II
Revogene, Catalog no. 610210. IVD test instrument
Meridian Bioscience Inc
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.
Sold states
Worldwide distribution - US Nationwide and the countries of Australia, Chile, Italy, Qatar, and Switzerland.
Affected count
459 (394 US, 65 OUS)
Manufactured in
3471 River Hills Dr, Cincinnati, OH, United States
Products
Revogene, Catalog no. 610210. IVD test instrument
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1479-2022Don't want to check this manually?
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