Recall Z-1541-2021 ยท QJR Reagents, 2019-Novel Coronavirus Nucleic Acid
Meridian Bioscience Inc
Revogene RNA Software Upgrade Kit Revogene RNA Software Upgrade USBs Catalog Number: 610240 IVD used to install the Revogene System Software version 4.2.0, import the Revogene Instrument Control Protocol file for RNA-based assay, and install the Assay Definition File (ADF) file
| 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| Reason | Emergency Use Application (EUA) application withdrawn as false negative results reported |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 | 124 Revogene RNA Software Upgrade Kits |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.