BEUDAMED
    FDA Enforcement Class II Terminated

    QUIDEL Sofia SARS Antigen FIA IVD REF 20374

    Recall: Z-0428-2021 · Reported November 18, 2020

    Enforcement

    Recall Number
    Z-0428-2021
    Event ID
    86550
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Quidel Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    November 18, 2020
    Initiation Date
    September 25, 2020
    Classification Date
    November 6, 2020
    Termination Date
    September 18, 2024
    Address
    10165 McKellar Ct, San Diego, CA, 92121-4201, United States

    Description

    QUIDEL Sofia SARS Antigen FIA IVD REF 20374

    Reason

    Due to false positive results.

    Code Info

    Model Number 20374 Lot Number: 706142 UPC A GTIN-12: 0 14613 33908 2 Cassettes: 168365 through 166817

    Distribution

    U.S.: AL, AR, AZ, CA, FL, GA, IN, LA, MO, MS, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WY

    Quantity

    8,628 kits