FDA recall Z-1540-2021

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 for recall

Emergency Use Application (EUA) application withdrawn as false negative results reported

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2021-04-08

Report date

2021-05-19

Termination date

2021-10-26

Voluntary/Mandated

Voluntary: Firm initiated

Location

Cincinnati, OH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1540-2021