FDA Enforcement
Class II
Terminated
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
Recall: Z-1540-2021
·
Reported May 19, 2021
Enforcement
- Recall Number
- Z-1540-2021
- Event ID
- 87556
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Meridian Bioscience Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- May 19, 2021
- Initiation Date
- April 8, 2021
- Classification Date
- May 7, 2021
- Termination Date
- October 26, 2021
- Address
- 3471 River Hills Dr, Cincinnati, OH, 45244-3023, United States
Description
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
Reason
Emergency Use Application (EUA) application withdrawn as false negative results reported
Code Info
All lot numbers
Distribution
Nationwide
Quantity
376 kits of the Revogene SARS-CoV-2 assay