FDA recall Z-1541-2021

Meridian Bioscience Inc · Class II · device

Product

Revogene RNA Software Upgrade Kit Revogene RNA Software Upgrade USBs Catalog Number: 610240 IVD used to install the Revogene System Software version 4.2.0, import the Revogene Instrument Control Protocol file for RNA-based assay, and install the Assay Definition File (ADF) file

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Emergency Use Application (EUA) application withdrawn as false negative results reported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-1541-2021