FDA-Device2021-05-19Class II
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
Meridian Bioscience Inc
Hazard
Emergency Use Application (EUA) application withdrawn as false negative results reported
Sold states
Nationwide
Affected count
124 Revogene RNA Software Upgrade Kits
Manufactured in
3471 River Hills Dr, Cincinnati, OH, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1541-2021Don't want to check this manually?
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