Meridian Bioscience Inc recalls Revogene RNA Software Upgrade Kit Revogene RNA Software Upgrade USBs Catalog Number: 610240 IVD used to install the

Recalled May 19, 2021 · FDA recall Z-1541-2021 · Meridian Bioscience

Hazard

Emergency Use Application (EUA) application withdrawn as false negative results reported · FDA Class II

Units

124 Revogene RNA Software Upgrade Kits

Sold at

Nationwide

Description

Emergency Use Application (EUA) application withdrawn as false negative results reported

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

Manufacturer(s)

Meridian Bioscience Inc

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →