BEUDAMED
    FDA Enforcement Class II Ongoing

    therascreen KRAS RGQ PCR Kit (24) REF 874052 (Japan IVD, not released in the USA)

    Recall: Z-0952-2022 · Reported April 27, 2022

    Enforcement

    Recall Number
    Z-0952-2022
    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) REF 874052 (Japan IVD, not released in the USA)

    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

    Distribution

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

    Quantity

    8 Kits