Device product
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
Z-1540-2021
Product summary
- Event
- Event 87556
- Status
- Terminated
- Classification
- Class II
- Quantity
- 376 kits of the Revogene SARS-CoV-2 assay
- Official record key
device-enforcement:Z-1540-2021
Official wording
Reason: Emergency Use Application (EUA) application withdrawn as false negative results reported
Code information: All lot numbers
Distribution pattern: Nationwide
Derived failure modes
-
Unknown
Emergency Use Application (EUA) application withdrawn as false negative results reported