Recall Z-1540-2021 ยท QJR Reagents, 2019-Novel Coronavirus Nucleic Acid
Meridian Bioscience Inc
Revogene SARS-CoV-2 Catalog Number: 410700 IVD for real-time Reverse Transcription Polymerase Chain Reaction (rRT-PCR) qualitative test run on the Revogene instrument for the detection of SARS-CoV-2 nucleic acid from nasopharyngeal swab (NPS) specimens from individuals suspected of COVID-19
| Date | Apr 8, 2021 |
| Status | Terminated |
| Reason | Emergency Use Application (EUA) application withdrawn as false negative results reported |
| Root cause | Under Investigation by firm |
| Action | Meridan issued Urgent Medical Device Recall on 4/08/21 to the user level via phone and electronic mailing . Letter states reason for recall, health risk and action to take: Revogene SARS-CoV-2, Catalog 410700: Laboratorys should consider evaluating patient test results per laboratory policies and procedures. Review current inventory and segregate any remaining stock. Contact Meridian Technical Support 800.343.3858 to obtain a FedEx label to return any remaining unexpired inventory to Meridian Bioscience Inc. Any expired inventory should be destroyed in accordance with facility protocols. |
| Quantity | 376 kits of the Revogene SARS-CoV-2 assay |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.