FDA recall Z-1479-2022

Meridian Bioscience Inc · Class II · device

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.

Distribution

Worldwide distribution - US Nationwide and the countries of Australia, Chile, Italy, Qatar, and Switzerland.

Key facts

Status
Ongoing
Initiation date
2022-06-22
Report date
2022-08-03
Voluntary/Mandated
Voluntary: Firm initiated
Location
Cincinnati, OH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1479-2022