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
Reported: May 19, 2021 Initiated: April 8, 2021 #Z-1540-2021
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Emergency Use Application (EUA) application withdrawn as false negative results reported
Details
- Recalling Firm
- Meridian Bioscience Inc
- Units Affected
- 376 kits of the Revogene SARS-CoV-2 assay
- Distribution
- Nationwide
- Location
- Cincinnati, OH
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Meridian Bioscience Inc. Units affected: 376 kits of the Revogene SARS-CoV-2 assay.
Why was this product recalled? ▼
Emergency Use Application (EUA) application withdrawn as false negative results reported
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 19, 2021. Severity: Moderate. Recall number: Z-1540-2021.
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