Recall Z-1479-2022— Meridian Bioscience Inc
Class II · Ongoing
Class II FDA medical device recall by Meridian Bioscience Inc, initiated 2022-06-22. It names one FDA 510(k) clearance: K170558. Product: Revogene, Catalog no. 610210. IVD test instrument. 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..
- Recalling firm
- Meridian Bioscience Inc
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2022-06-22
- Firm location
- Cincinnati, OH, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.