BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BINAXNOW COVID-19 AG SELF TEST 2CT

    MDR report key: 24967194 · Received April 23, 2026

    Report

    Report Number
    1221359-2026-00056
    Event Type
    Malfunction
    Date Received
    April 23, 2026
    Date of Event
    April 9, 2026
    Report Date
    April 23, 2026
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    QYT
    PMA / PMN Number
    K243518
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: THE REQUIRED INFORMATION TO ENABLE FURTHER INVESTIGATION, SUCH AS THE KIT'S LOT NUMBER, WAS NOT PROVIDED AND AN INVESTIGATION WAS NOT ABLE TO BE PERFORMED. A PRODUCT DEFICIENCY COULD NOT BE DETERMINED. NOTWITHSTANDING, COMPLAINTS AGAINST THESE TREND CODES ARE MONITORED TO IDENTIFY AND TRACK ANY OUT-OF-TREND / UNEXPECTED PERFORMANCE AT THE LOT AND PRODUCT FAMILY LEVEL. IN CONCLUSION, ABBOTT DIAGNOSTICS SCARBOROUGH WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUES AS NO INFORMATION WAS PROVIDED FOR INVESTIGATION.

    Description of Event or Problem · 0

    THE CONSUMER REPORTED A FALSE POSITIVE RESULT WITH THE ADDITIONAL TESTING WAS PERFORMED WITH AN UNKNOWN BRAND RAPID COVID-19 TEST ON AN UNKNOWN DATE AFTER THE INITIAL POSITIVE RESULT THAT GENERATED A NEGATIVE RESULT. ALTHOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64497 BINAXNOW COVID-19 AG SELF TEST 2CT CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. QYT ABBOTT DIAGNOSTICS SCARBOROUGH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown