BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BINAXNOW COVID-19 AG SELF TEST 2CT

    MDR report key: 25056988 · Received May 1, 2026

    Report

    Report Number
    1221359-2026-00063
    Event Type
    Malfunction
    Date Received
    May 1, 2026
    Date of Event
    May 1, 2025
    Report Date
    May 13, 2026
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    QYT
    UDI-DI
    00811877011408
    PMA / PMN Number
    K243518
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    B2: EVENT DATE: DATE IS AN APPROXIMATION AS THE EXACT DATE OF THE EVENT WAS NOT REPORTED. THE INVESTIGATION IS ONGOING; A SUPPLEMENT REPORT WILL BE SENT UPON COMPLETION.

    Description of Event or Problem · 0

    THE CONSUMER REPORTED A FALSE POSITIVE RESULT WITH THE BINAXNOW COVID-19 SELF-TEST ON AN UNKNOWN DATE ON (B)(6) 2025. THE CONSUMER INDICATED THAT THE RESULT SHOWED A DARK PINK CONTROL LINE AND A FAINT PINK SAMPLE LINE (INDICATES A POSITIVE RESULT) AND WAS UNSURE IF THE RESULT WAS POSITIVE. DUE TO WHAT THE CONSUMER REPORTED AS AN INCONCLUSIVE RESULT, THEY VISITED AN URGENT CARE CENTER WHERE AN UNKNOWN COVID-19 RAPID TEST WAS PERFORMED THAT PRESENTED A NEGATIVE RESULT. THE CONSUMER REPORTED TO HAVE BEEN SYMPTOMATIC INCLUDING A MILD SORE THROAT. NO NEGATIVE IMPACT WAS REPORTED AS A RESULT. NO FURTHER INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    276218 BINAXNOW COVID-19 AG SELF TEST 2CT CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. QYT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 886120 00811877011408

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown