BEUDAMED
    FDA Enforcement Class II Terminated

    therascreen PIK3CA RGQ PCR Kit (23) US IVD product- aid clinicians in identifying breast cancer patients who may be eligible for treatment with PIQRAY (alpelisib) based on a PIK3CA Mutation Detected result. REF 873121

    Recall: Z-0937-2021 · Reported February 3, 2021

    Enforcement

    Recall Number
    Z-0937-2021
    Event ID
    87047
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Qiagen Sciences LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    February 3, 2021
    Initiation Date
    December 11, 2020
    Classification Date
    January 28, 2021
    Termination Date
    April 22, 2022
    Address
    19300 Germantown Rd, Germantown, MD, 20874-1415, United States

    Description

    therascreen PIK3CA RGQ PCR Kit (23) US IVD product- aid clinicians in identifying breast cancer patients who may be eligible for treatment with PIQRAY (alpelisib) based on a PIK3CA Mutation Detected result. REF 873121

    Reason

    Kit may generate false Q546R mutation positive results caused by nonspecific molecular interactions within the Q546R higher than previously observed and described within the Instructions For Use.

    Code Info

    All lots

    Distribution

    CA, IN, MI, MN, NC, NJ, NM, OH, TX

    Quantity

    575 kits US