Recall Z-1008-2023— Meridian Bioscience Inc
Class II · Ongoing
Class II FDA medical device recall by Meridian Bioscience Inc, initiated 2022-12-15. FDA's recall record names no specific 510(k) clearance for this event. Product: Revogene SARS-CoV-2_IVD real-time RT-PCR test intended for the qualitative detection of RNA from SARSCoV-2 Catalog Number: 410700. Reason: Leakage of the original specimen from the plastic microfluidic cartridge (PIE), possibility that laboratory personnel may be exposed to aerosolized specimen containing SARS-CoV-2.
- Recalling firm
- Meridian Bioscience Inc
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2022-12-15
- Firm location
- Cincinnati, OH, United States
Product description
Revogene SARS-CoV-2_IVD real-time RT-PCR test intended for the qualitative detection of RNA from SARSCoV-2 Catalog Number: 410700
Reason for recall
Leakage of the original specimen from the plastic microfluidic cartridge (PIE), possibility that laboratory personnel may be exposed to aerosolized specimen containing SARS-CoV-2
Data sourced from openFDA. This site is unofficial and independent of the FDA.