BEUDAMED
    FDA Enforcement Class II Terminated

    SARS-CoV-2 Antigen Test

    Recall: Z-0941-2021 · Reported February 10, 2021

    Enforcement

    Recall Number
    Z-0941-2021
    Event ID
    87205
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Qiagen Sciences LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Other
    Report Date
    February 10, 2021
    Initiation Date
    January 15, 2021
    Classification Date
    January 31, 2021
    Termination Date
    July 11, 2022
    Address
    19300 Germantown Rd, Germantown, MD, 20874-1415, United States

    Description

    SARS-CoV-2 Antigen Test

    Reason

    QIAGEN has become aware of the potential for false positive results to occur with some patient samples.

    Code Info

    GTIN: 04053228039785, Catalog #: 646533, Lot #: 86651, 86652, 86653, 86654, 86659.

    Distribution

    Domestic: AZ, CA, DC, CO,FL,HI, IL, KY, MI, MO, NC, NJ, NM, NY, OH, RI, TX, WA, WY

    Quantity

    1092 boxes of 60 (65,520 e-sticks)