Recall Z-1540-2021— Meridian Bioscience Inc
Class II · Terminated
Class II FDA medical device recall by Meridian Bioscience Inc, initiated 2021-04-08, terminated 2021-10-26. FDA's recall record names no specific 510(k) clearance for this event. 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. Reason: Emergency Use Application (EUA) application withdrawn as false negative results reported.
- Recalling firm
- Meridian Bioscience Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2021-04-08
- Terminated
- 2021-10-26
- Firm location
- Cincinnati, OH, United States
Product 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 for recall
Emergency Use Application (EUA) application withdrawn as false negative results reported
Data sourced from openFDA. This site is unofficial and independent of the FDA.