BEUDAMED
    FDA Enforcement Class II Terminated

    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: Z-1541-2021 · Reported May 19, 2021

    Enforcement

    Recall Number
    Z-1541-2021
    Event ID
    87556
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Meridian Bioscience Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 19, 2021
    Initiation Date
    April 8, 2021
    Classification Date
    May 7, 2021
    Termination Date
    October 26, 2021
    Address
    3471 River Hills Dr, Cincinnati, OH, 45244-3023, United States

    Description

    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

    Emergency Use Application (EUA) application withdrawn as false negative results reported

    Code Info

    All lot numbers

    Distribution

    Nationwide

    Quantity

    124 Revogene RNA Software Upgrade Kits