BEUDAMED
    FDA Recall Open, Classified

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

    Recall: Z-2545-2025 · Initiated June 17, 2025

    Recall

    Recall Number
    Z-2545-2025
    Event Number
    97271
    Firm
    Quidel Corporation
    FEI Number
    2024674
    Product Code
    GTY
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    June 17, 2025
    Posted
    September 10, 2025
    Address
    10165 McKellar Ct, San Diego, CA, 92121-4201

    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.

    Action

    On 6/17/2025, correction notices were mailed to customers who were asked to do the following: 1) Send the enclosed customer letter and Confirmation of Receipt form to customers who were shipped any of the affected lots of Strep A Test from your facility. 2) The response form asks customers to acknowledge they have discontinued distributing and discarded the affected lots of Strep A Test 3) Complete and return the Confirmation of Receipt form via email to [email protected] If you have further questions, please contact the firm's Global Services Organization at 1-800-874-1517 or [email protected].

    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