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
- Company
- Meridian Bioscience Inc
- Recall Initiated
- April 8, 2021
- Terminated
- October 26, 2021
- Recall Number
- Z-1540-2021
- Quantity
- 376 kits of the Revogene SARS-CoV-2 assay
- Firm Location
- Cincinnati, OH
Reason for Recall
Emergency Use Application (EUA) application withdrawn as false negative results reported
Distribution
Nationwide
Lot / Code Info
All lot numbers
Root Cause
Under Investigation by firm
Action Taken
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. Complete and return the Customer Notification Form. This will indicate receipt of this field correction notice. Revogene RNA Software Upgrade Kit, Catalog 610240: Review current inventory and segregate any remaining stock of the RNA Software kit, including the USB. Contact Meridian Technical Support 800.343.3858 to obtain a FedEx label to return remaining unexpired inventory to Meridian Bioscience, Inc. Any expired inventory should be destroyed in accordance with facility protocols. Complete and return the Customer Notification Form. This will indicate receipt of this field correction notice. Actions to Be Taken By Meridian: Meridian intends to conduct additional validation and bridging studies with the intention of re-submitting an EUA application for its SARS-CoV-2 test on the Revogene platform as soon as possible thereafter. Contact Information: If you have any questions, please call Meridian Bioscience Technical Services at 1-800-343-3858, or email at MBI-TechService@meridianbioscience.com.