BEUDAMED
    FDA Enforcement Class II Ongoing

    therascreen KRAS RGQ PCR Kit (24) Model Number(s): REF 870021 (US IVD)

    Recall: Z-0951-2022 · Reported April 27, 2022

    Enforcement

    Recall Number
    Z-0951-2022
    Event ID
    89914
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Qiagen Sciences LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Report Date
    April 27, 2022
    Initiation Date
    February 25, 2022
    Classification Date
    April 18, 2022
    Address
    19300 Germantown Rd, Germantown, MD, 20874-1415, United States

    Description

    therascreen KRAS RGQ PCR Kit (24) Model Number(s): REF 870021 (US IVD)

    Reason

    False positive or false negative G12C (12CYS) mutation result for the KRAS Mutation Status resulting from Flags/Warnings may invalidate the result for one or more individual mutation target of the kit.

    Code Info

    All lot numbers. GTIN number: 04053228002048

    Distribution

    AZ CA CT FL GA IL IN MA MN NC NY OK OR PA TN TX WV

    Quantity

    435 kits