BEUDAMED
    FDA Enforcement Class II Terminated

    therascreen EGFR RGQ PCR Kit (24), Reference Number REF 870121

    Recall: Z-2290-2020 · Reported June 17, 2020

    Enforcement

    Recall Number
    Z-2290-2020
    Event ID
    85565
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Qiagen Sciences LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 17, 2020
    Initiation Date
    April 8, 2020
    Classification Date
    June 5, 2020
    Termination Date
    June 3, 2021
    Address
    19300 Germantown Rd, N/A, Germantown, MD, 20874-1415, United States

    Description

    therascreen EGFR RGQ PCR Kit (24), Reference Number REF 870121

    Reason

    There is a risk for a false mutation positive result in rare cases resulting from a fluorescence artefact. In these rare cases, the controls pass correctly, while a fluorescence artefact in the mutation assay causes an incorrect valid mutation positive result.

    Code Info

    All lots

    Distribution

    US Nationwide.

    Quantity

    530 kits within expiry