BEUDAMED
    FDA Enforcement Class II Ongoing

    FGFR RGQ RT-PCR Kit (RUO, not IVD) REF 8747010

    Recall: Z-1652-2022 · Reported September 7, 2022

    Enforcement

    Recall Number
    Z-1652-2022
    Event ID
    90691
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Qiagen Sciences LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    September 7, 2022
    Initiation Date
    July 20, 2022
    Classification Date
    August 29, 2022
    Address
    19300 Germantown Rd, Germantown, MD, 20874-1415, United States

    Description

    FGFR RGQ RT-PCR Kit (RUO, not IVD) REF 8747010

    Reason

    Increased occurrence rate of false positive results, lead to a false positive sample result that could subsequently be incorrectly reported from the laboratory. A false positive result could lead to the risk of the patient being exposed to an inappropriate or suboptimal anti-cancer treatment and/or unnecessarily experiencing side effects

    Code Info

    Lot number: 169047135 Exp Date: 12.06.2022 172017806 Exp. Date: 10.11.2022

    Distribution

    IN, NC, MN, TX Foreign: Belgium, China, Germany, Jordan, Italy, Netherlands, Malaysia, Spain, Thailand

    Quantity

    9 kits