Recall Z-1008-2023 ยท QJR Reagents, 2019-Novel Coronavirus Nucleic Acid
Meridian Bioscience Inc
Revogene SARS-CoV-2_IVD real-time RT-PCR test intended for the qualitative detection of RNA from SARSCoV-2 Catalog Number: 410700
| Date | Jan 20, 2023 (initiated Dec 15, 2022) |
| Status | Open, Classified |
| 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 |
| Root cause | Process control |
| Action | Meridian Bioscience issued Urgent Medical Device Recall on 12/15/22 via email. The letter states reason for recall, health risk and action to take: REQUIRED ACTIONS: " Inspect the rotor, ring, and chamber walls of the Revogene instrument for signs of leakage (e.g., dried spots). Contact Meridian Bioscience Technical Service if any signs of leakage were detected. " If leakage is suspected, clean the Revogene, MOCK PIEs, and surrounding workspace using the instructions in the Revogene operator's manual. " Review current inventory and segregate any remaining stock. " Discontinue use of any remain |
| Quantity | 92 kits |
| Distribution | US Nationwide distribution in the states of AZ, CA, IN, KS, KY, LA, MI, MN, NC, NY, OR, TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.