BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BINAXNOW COVID-19 AG SELF TEST 4CT

    MDR report key: 23783254 · Received December 11, 2025

    Report

    Report Number
    1221359-2025-00850
    Event Type
    Malfunction
    Date Received
    December 11, 2025
    Date of Event
    December 1, 2025
    Report Date
    February 24, 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

    B3, DATE OF EVENT: THIS DATE IS AN APPROXIMATION AS THE ACTUAL DATE OF EVENT COULD NOT BE CONFIRMED. THE INVESTIGATION IS ONGOING, A SUPPLEMENT REPORT WILL BE SENT UPON COMPLETION.

    Additional Manufacturer Narrative · 0

    B3, DATE OF EVENT: THIS DATE IS AN APPROXIMATION AS THE ACTUAL DATE OF EVENT COULD NOT BE CONFIRMED. INVESTIGATION SUMMARY THE REQUIRED INTAKE INFORMATION COULD NOT BE OBTAINED FROM THE CUSTOMER. THE INFORMATION TO ENABLE FURTHER INVESTIGATION, SUCH AS THE KIT'S LOT NUMBER, WAS NOT PROVIDED AND AN INVESTIGATION WAS NOT ABLE TO BE PERFORMED. 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.

    Description of Event or Problem · 0

    THE CONSUMER REPORTED, VIA SOCIAL MEDIA, A FALSE POSITIVE RESULT WITH THE BINAXNOW COVID-19 ANTIGEN SELF-TEST PERFORMED ON AN UNKNOWN DATE. THE CONSUMER REPORTED THAT THEIR SPOUSE, WHO WAS SYMPTOMATIC WITH UNSPECIFIC SYMPTOMS, TESTED TWICE ON THE SAME DAY WITH THE BINAXNOW COVID-19 ANTIGEN SELF-TEST; THE FIRST TEST GENERATED AN INVALID RESULT (TEST STRIP TURNED HAZY RED), THE SECOND TEST RESULT WAS DIFFICULT TO READ AS THE TEST STRIP WAS A HAZY RED YET ALSO SHOWED A CONTROL AND SAMPLE LINE INDICATING A POSITIVE RESULT. THE CONSUMER STATED THAT PER THE ADVICE OF A DOCTOR, A DIFFERENT SET OF TESTS WAS OBTAINED (CVS BRANDED COVID-19 FLU A/B COMBO) AND TESTING WAS PERFORMED FOR THE NEXT THREE DAYS, ALL RESULTS WERE NEGATIVE. NO ADDITIONAL INFORMATION WAS REPORTED AND IS UNABLE TO BE OBTAINED AS NO CONTACT INFORMATION WAS PROVIDED.

    Description of Event or Problem · 0

    THE CONSUMER REPORTED, VIA SOCIAL MEDIA, A FALSE POSITIVE RESULT WITH THE BINAXNOW COVID-19 ANTIGEN SELF-TEST PERFORMED ON AN UNKNOWN DATE. THE CONSUMER REPORTED THAT THEIR SPOUSE, WHO WAS SYMPTOMATIC WITH UNSPECIFIC SYMPTOMS, TESTED TWICE ON THE SAME DAY WITH THE BINAXNOW COVID-19 ANTIGEN SELF-TEST; THE FIRST TEST GENERATED AN INVALID RESULT (TEST STRIP TURNED HAZY RED), THE SECOND TEST RESULT WAS DIFFICULT TO READ AS THE TEST STRIP WAS A HAZY RED YET ALSO SHOWED A CONTROL AND SAMPLE LINE INDICATING A POSITIVE RESULT. THE CONSUMER STATED THAT PER THE ADVICE OF A DOCTOR, A DIFFERENT SET OF TESTS WAS OBTAINED (CVS BRANDED COVID-19 FLU A/B COMBO) AND TESTING WAS PERFORMED FOR THE NEXT THREE DAYS, ALL RESULTS WERE NEGATIVE. NO ADDITIONAL INFORMATION WAS REPORTED AND IS UNABLE TO BE OBTAINED AS NO CONTACT INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2186106 BINAXNOW COVID-19 AG SELF TEST 4CT CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. QYT ABBOTT DIAGNOSTICS SCARBOROUGH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown