BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABBOTT BINAXNOW COVID-19 TESTS

    MDR report key: 17926373 · Received October 11, 2023

    Report

    Report Number
    MW5146906
    Event Type
    Malfunction
    Date Received
    October 11, 2023
    Date of Event
    October 5, 2023
    Report Date
    October 5, 2023
    Manufacturer
    ABBOTT DIAGNOSTICS, SCARBOROUGH, INC.
    Product Code
    QKP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    WE WERE OFFERED 2 FREE COVID TESTS, SO WE ACCEPTED. I RECEIVED THOSE TODAY, AND FOUND BOTH BOXES OF TESTS WERE EXPIRED 3 FULL MONTHS AGO. WE WERE DIRECTED TO THE FDA WEBSITE TO CHECK FOR PRODUCT EXTENSION. THE ONES WE RECEIVED, LOT #202564, WERE NOT LISTED ANYWHERE. FDA WEBSITE ALSO SAYS, IF THEY WERE NOT EXTENDED, AND NOT LISTED DO NOT USE THEM. THIS IS SOME SERIOUS BS. IS THE FDA MAILING OUT MILLIONS OF USELESS / EXPIRED TESTS? JUST TO GET RID OF THEM? UNBELIEVABLE, YET NOT, NOW THAT I THINK ABOUT IT. WHAT ARE OUR OPTIONS AT THIS TIME, PLEASE? WORDS TRULY CANNOT CONVEY HOW STUPID AND RIDICULOUS AND WRONG THIS SITUATION, IS. REF REPORT: MW5146905.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1768474 ABBOTT BINAXNOW COVID-19 TESTS CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM QKP ABBOTT DIAGNOSTICS, SCARBOROUGH, INC. 195-160 202564

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Male