BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABBOTT BINAXNOW COVID-19 ANTIGEN SELF TEST

    MDR report key: 17931034 · Received October 12, 2023

    Report

    Report Number
    MW5146919
    Event Type
    Malfunction
    Date Received
    October 12, 2023
    Date of Event
    October 7, 2023
    Report Date
    October 8, 2023
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    QKP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    JUST RECEIVED FOUR (4) NEW BINAXNOW COVID-19 TESTS VIA USPS (UNITED STATES POSTAL SERVICE). THEY ARRIVED WITH AN EXPIRATION DATE OF 2023-07-19. ALREADY EXPIRED. THEY ARE NOT ON THE FDA (FOOD AND DRUG ADMINISTRATION) EXTENDED DATE LISTING. OBVIOUSLY NOT USABLE AS THEY HAVE EXPIRED. REALLY WONDER WHY THEY WERE SENT OUT. WHAT I GOT WAS THE ABBOTT BINAXNOW COVID-19 ANTIGEN SELF TEST, REF # (B)(4), EXPIRATION 2023-07-19, LOT #203278. REFERENCE REPORT: MW5146920.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1983938 ABBOTT BINAXNOW COVID-19 ANTIGEN SELF TEST CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM QKP ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 195-160 203278

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Female