Meridian Bioscience Inc recalls Revogene SARS-CoV-2 Catalog Number: 410700 IVD for real-time Reverse Transcription Polymerase Chain Reaction (rRT-P

Recalled May 19, 2021 · FDA recall Z-1540-2021 · Meridian Bioscience

Hazard

Emergency Use Application (EUA) application withdrawn as false negative results reported · FDA Class II

Units

376 kits of the Revogene SARS-CoV-2 assay

Sold at

Nationwide

Description

Emergency Use Application (EUA) application withdrawn as false negative results reported

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

Manufacturer(s)

Meridian Bioscience Inc

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →