medical Class II Updated 2021-05-19

Meridian Bioscience Inc recalls Revogene RNA Software Upgrade Kit Revogene RNA Software Upg

Recalled 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

Hazard / Issue

Emergency Use Application (EUA) application withdrawn as false negative results reported

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: All lot numbers
View official government recall

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