BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABBOTT BINAXNOW COVID-19 TESTS

    MDR report key: 17926357 · Received October 11, 2023

    Report

    Report Number
    MW5146905
    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 "PROFANITY". 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. IF I DO NOT HEAR FROM SOMEONE REGARDING THIS MATTER, I WILL BE EXTREMELY DISAPPOINTED, AND QUESTIONING OF THE LEGITIMACY OF THIS ENTIRE PROGRAM AND THE NECESSITY OF IT. REF REPORT: MW5146906.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1768473 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