BEUDAMED
    FDA Enforcement Class II Ongoing

    QuickVue: Dipstick Strep A Test: 50T, REF: 20108; 25T, REF: 20125; 50T, SCN, REF: 20108SC

    Recall: Z-2545-2025 · Reported September 17, 2025

    Enforcement

    Recall Number
    Z-2545-2025
    Event ID
    97271
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Quidel Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 17, 2025
    Initiation Date
    June 17, 2025
    Classification Date
    September 10, 2025
    Address
    10165 McKellar Ct, N/A, San Diego, CA, 92121-4201, United States

    Description

    QuickVue: Dipstick Strep A Test: 50T, REF: 20108; 25T, REF: 20125; 50T, SCN, REF: 20108SC

    Reason

    Dipstick strep A test has potential for false positive results.

    Code Info

    REF/UDI-DI/Lot(Expiration): 20108/30014613201083/709673(05-FEB-2026), 709676(05-FEB-2026), 709484(09-JAN-2026), 709501(09-JAN-2026), 709520(16-JAN-2026), 709535(16-JAN-2026); 20125/30014613201250/709487(09-JAN-2026), 709503(16-JAN-2026), 709509(16-JAN-2026), 709684(12-FEB-2026); 20108SC/0130014613330073/709485(09-JAN-2026), 709502(16-JAN-2026)

    Distribution

    Worldwide - US Nationwide distribution in the states of MA, NJ, MD, NC, SC, FL, TN, MS, MN, IL, MO, KS, LA, TX, CO, ID, CA, AK, NY, PA and the countries of Canada, Italy, Denmark, Norway, Sweden, Finland, Thailand, Israel, Slovenia, Turkey.

    Quantity

    22470