BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BINAXNOW COVID-19 AG SELF TEST 2CT

    MDR report key: 23335254 · Received October 20, 2025

    Report

    Report Number
    1221359-2025-00464
    Event Type
    Malfunction
    Date Received
    October 20, 2025
    Date of Event
    October 14, 2025
    Report Date
    January 27, 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
    NY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION REMAINS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION.

    Additional Manufacturer Narrative · 0

    TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 000920382A WITH INTERNAL POSITIVE QUALITY CONTROL SAMPLES AND NEGATIVE QUALITY CONTROL SWABS. ALL TEST RESULTS WERE VALID AND PERFORMED AS EXPECTED. ADDITIONALLY, THE MANUFACTURING RECORDS AND QUALITY CONTROL RELEASE TESTING WAS REVIEWED FOR TEST KIT PART NUMBER 195-160 / LOT: 000920382A, DEVICE PART NUMBER 195-430WJR / LOT: 920382. THE LOT MET THE REQUIRED RELEASE SPECIFICATIONS. A REVIEW OF THE COMPLAINTS REPORTED AS FALSE POSITIVE PATIENT RESULTS (CONFIRMED AND UNCONFIRMED, CONFLICTING RESULTS) RELATED TO KIT LOT 000920382A SHOWED THAT THE COMPLAINT RATE IS (B)(4). ABBOTT DIAGNOSTICS SCARBOROUGH, INC. WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A FALSE POSITIVE RESULT WITH THE BINAXNOW COVID-19 AG SELF TEST PERFORMED ON (B)(6) 2025. A TELEHEALTH VISIT WAS COMPLETED AFTER TESTING AND THE DOCTOR DIAGNOSED THE CUSTOMER WITH A COLD. NO COVID-19 DIAGNOSIS WAS GIVEN. THE DOCTOR ADVISED THAT NO FURTHER TESTING OR TREATMENT WAS NECESSARY.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A FALSE POSITIVE RESULT WITH THE BINAXNOW COVID-19 AG SELF TEST PERFORMED ON (B)(6) 2025. A TELEHEALTH VISIT WAS COMPLETED AFTER TESTING AND THE DOCTOR DIAGNOSED THE CUSTOMER WITH A COLD. NO COVID-19 DIAGNOSIS WAS GIVEN. THE DOCTOR ADVISED THAT NO FURTHER TESTING OR TREATMENT WAS NECESSARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323172 BINAXNOW COVID-19 AG SELF TEST 2CT CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. QYT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 000920382A 00811877011408

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown