BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BINAXNOW COVID-19 AG SELF TEST 4CT

    MDR report key: 23465649 · Received November 4, 2025

    Report

    Report Number
    1221359-2025-00813
    Event Type
    Malfunction
    Date Received
    November 4, 2025
    Date of Event
    October 13, 2025
    Report Date
    November 21, 2025
    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: THE DATE INDICATED IS AN APPROXIMATION AS THE EXACT EVENT DATES WERE NOT PROVIDED. THE INVESTIGATION REMAINS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION.

    Additional Manufacturer Narrative · 0

    B3: THE DATE INDICATED IS AN APPROXIMATION AS THE EXACT EVENT DATES WERE NOT PROVIDED. THE REQUIRED INTAKE 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 FALSE NEGATIVE RESULTS (CONFIRMED, UNCONFIRMED, CONFLICTING) ARE MONITORED TO IDENTIFY AND TRACK ANY OUT-OF-TREND/UNEXPECTED PERFORMANCE AT THE LOT AND PRODUCT FAMILY LEVEL. 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 FALSE NEGATIVE RESULTS WITH THE BINAXNOW COVID-19 AG SELF TEST FOR MULTIPLE TESTS PERFORMED ON UNKNOWN DATES BETWEEN (B)(6) 2025. THIS MFR. REPORT ADDRESSES TEST FOUR (4) OF FOUR (4). THE CONSUMER REPORTED A FALSE NEGATIVE RESULT WITH THE BINAXNOW COVID-19 AG SELF TEST PERFORMED ON AN UNKNOWN DATE. PREVIOUS TESTING WAS CONDUCTED WITH ANOTHER BRAND (BRAND UNKNOWN) ON (B)(6) 2025 AND GENERATED POSITIVE RESULTS. THE CONSUMER REPORTED SEEING THEIR DOCTOR ON (B)(6) 2025 AND BEING DIAGNOSED WITH COVID-19. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

    Description of Event or Problem · 0

    THE CONSUMER REPORTED FALSE NEGATIVE RESULTS WITH THE BINAXNOW COVID-19 AG SELF TEST FOR MULTIPLE TESTS PERFORMED ON UNKNOWN DATES BETWEEN (B)(6) 2025. THIS MFR. REPORT ADDRESSES TEST FOUR (4) OF FOUR (4). THE CONSUMER REPORTED A FALSE NEGATIVE RESULT WITH THE BINAXNOW COVID-19 AG SELF TEST PERFORMED ON AN UNKNOWN DATE. PREVIOUS TESTING WAS CONDUCTED WITH ANOTHER BRAND (BRAND UNKNOWN) ON (B)(6) 2025 AND GENERATED POSITIVE RESULTS. THE CONSUMER REPORTED SEEING THEIR DOCTOR ON (B)(6) 2025 AND BEING DIAGNOSED WITH COVID-19. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    364801 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