BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COVID-19 ANTIGEN RAPID TEST

    MDR report key: 23839343 · Received December 18, 2025

    Report

    Report Number
    MW5180817
    Event Type
    Malfunction
    Date Received
    December 18, 2025
    Date of Event
    October 30, 2025
    Report Date
    December 11, 2025
    Manufacturer
    EQUATE, DISTRIBUTED BY WALMART / ANDON MEDICAL CO., LTD.
    Product Code
    QYT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AZ, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I USED AN EQUATE BRAND COVID-19 ANTIGEN RAPID TEST (AT-HOME TEST) AND THE CONTROL LINE DID NOT SHOW UP. THE TEST IS CONSIDERED INVALID AND FAULTY DUE TO THE CONTROL NOT WORKING. I USED ANOTHER BRAND OF AT-HOME TEST THE NEXT DAY IN WHICH THE CONTROL LINE DID WORK, AND I WAS COVID POSITIVE. THE FAULTY TEST DID NOT CAUSE ME OR ANYONE ELSE ANY HARM FOR THIS EVENT; HOWEVER, EQUATE/WALMART REFUSES TO DO ANYTHING ABOUT THE FAULTY TEST. I HAD PURCHASED 3 TESTS AND TRIED TO RETURN THE OTHER 2 AND THEY REFUSED STATING THEIR POLICY DOES NOT ACCEPT RETURNS ON COVID AT HOME TESTS. I CALLED THE NUMBER ON THE TEST BOX AND THEY PUT IN A NOTE TO THE SUPPLIER AND SAID I SHOULD HEAR BACK. I HAVE NOT HEARD BACK IN OVER A MONTH. WALMART/EQUATE NEED TO ADDRESS THE COMPLAINT THAT THE CONTROL LINE DID NOT WORK ON ONE OF THEIR COVID-19 AT HOME TESTS. I AM A MICROBIOLOGIST WHO SPECIALIZES IN QUALITY CONTROL SO I ASSURE YOU I KNOW HOW TO READ DIRECTIONS AND USE AN ELISA TEST PROPERLY; THE TEST KIT WAS FAULTY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2244366 COVID-19 ANTIGEN RAPID TEST OVER-THE-COUNTER COVID-19 ANTIGEN TEST QYT EQUATE, DISTRIBUTED BY WALMART / ANDON MEDICAL CO., LTD. 251CO10801

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Female Other