Company: Meridian Bioscience Inc
Date of Enforcement Report: 5/19/2021
Class II
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.
Recall Number: Z-1541-2021
REASON
Emergency Use Application (EUA) application withdrawn as false negative results reported.
RECALLING FIRM/MANUFACTURER
Meridian Bioscience Inc on 4/8/2021. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
124 Revogene RNA Software Upgrade Kits
DISTRIBUTION
U.S. Nationwide