BEUDAMED
    FDA Enforcement Class II Ongoing

    Revogene SARS-CoV-2_IVD real-time RT-PCR test intended for the qualitative detection of RNA from SARSCoV-2 Catalog Number: 410700

    Recall: Z-1008-2023 · Reported February 1, 2023

    Enforcement

    Recall Number
    Z-1008-2023
    Event ID
    91356
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Meridian Bioscience Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    February 1, 2023
    Initiation Date
    December 15, 2022
    Classification Date
    January 20, 2023
    Address
    3471 River Hills Dr, N/A, Cincinnati, OH, 45244-3023, United States

    Description

    Revogene SARS-CoV-2_IVD real-time RT-PCR test intended for the qualitative detection of RNA from SARSCoV-2 Catalog Number: 410700

    Reason

    Leakage of the original specimen from the plastic microfluidic cartridge (PIE), possibility that laboratory personnel may be exposed to aerosolized specimen containing SARS-CoV-2

    Code Info

    UDI: N/A Lot Numbers 410700P019, 410700P020, 410700P021, 410700P022, 410700P023, 410700P024, 410700P027

    Distribution

    US Nationwide distribution in the states of AZ, CA, IN, KS, KY, LA, MI, MN, NC, NY, OR, TX.

    Quantity

    92 kits