medical Class II Updated 2021-05-19

Meridian Bioscience Inc recalls Revogene SARS-CoV-2 Catalog Number: 410700 IVD for real

Recalled 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

Hazard / Issue

Emergency Use Application (EUA) application withdrawn as false negative results reported

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: All lot numbers
View official government recall

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