BEUDAMED
    FDA Recall Terminated

    QUIDEL Sofia SARS Antigen FIA IVD REF 20374

    Recall: Z-0428-2021 · Initiated September 25, 2020

    Recall

    Recall Number
    Z-0428-2021
    Event Number
    86550
    Firm
    Quidel Corporation
    FEI Number
    2024674
    Product Code
    PSZ
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    September 25, 2020
    Terminated
    September 18, 2024
    Address
    10165 McKellar Ct, San Diego, CA, 92121-4201

    Description

    QUIDEL Sofia SARS Antigen FIA IVD REF 20374

    Reason

    Due to false positive results.

    Action

    On 10/14/2020, the firm sent an "URGENT MEDICAL DEVICE RECALL" Notification via US Certified mail to customer informing them that a limited number of SARS Antigen FIA test cassettes have an increased potential for false positive results. Customers are instructed to stop using all product from the affected lot and return the unused product to the Recalling Firm for a replacement or issuance of credit fro any unused product. The specific instruction to customers are: 1. Stop using Sofia SARS Antigen FIA, Cat. #20374, Lot 706142. 2. Return the attached Verification Form with the amount of product that will be returned so a credit may be issued. The customer will be contacted to arrange the return of product and the corresponding credit. 3. Return any unused product from Sofia SARS Antigen FIA, Cat. #20374, Lot 706142. 4. In the event that the customer's facility has used this lot number to report patient results, please contact Technical Support at [email protected]. Technical Support will conduct an analyzer log data review to determine if any reported patient results were impacted.

    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