BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BINAXNOW COVID-19 AG SELF TEST 2CT

    MDR report key: 23708554 · Received December 3, 2025

    Report

    Report Number
    1221359-2025-00845
    Event Type
    Malfunction
    Date Received
    December 3, 2025
    Date of Event
    November 1, 2025
    Report Date
    December 24, 2025
    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

    B3, DATE OF EVENT: THIS DATE IS AN APPROXIMATION AS THE CONSUMER DID NOT PROVIDE THE ACTUAL DATE OF EVENT. INVESTIGATION SUMMARY: TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 000905503A 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 000905503A AND DEVICE PART NUMBER 195-430WL LOT 905503. THE LOT MET THE REQUIRED RELEASE SPECIFICATIONS. A REVIEW OF THE COMPLAINTS REPORTED AS FALSE NEGATIVE PATIENT RESULTS (CONFIRMED AND UNCONFIRMED, CONFLICTING RESULTS) RELATED TO KIT LOT 000905503A SHOWED THAT THE COMPLAINT RATE IS (B)(4). ABBOTT DIAGNOSTICS SCARBOROUGH, INC. WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE; HOWEVER, IT COULD POSSIBLY BE RELATED TO ISSUES INCLUDING THE SELF-TEST USER PERFORMANCE, INTERPRETATION OF THE RESULT, OR THE SPECIFIC PATIENT SAMPLE.

    Additional Manufacturer Narrative · 0

    B3, DATE OF EVENT: THIS DATE IS AN APPROXIMATION AS THE CONSUMER DID NOT PROVIDE THE ACTUAL DATE OF EVENT. THE INVESTIGATION IS ONGOING, AND A SUPPLEMENT REPORT WILL BE SUBMITTED UPON COMPLETION.

    Description of Event or Problem · 0

    THE CONSUMER REPORTED A FALSE NEGATIVE RESULT WITH THE BINAXNOW COVID-19 AG SELF TEST PERFORMED ON AN UNKNOWN DATE. THE CONSUMER REPORTED HAVING BEEN SYMPTOMATIC WITH LOSS OF TASTE AND A POSSIBLE SINUS INFECTION. NO ADDITIONAL TESTING WAS PERFORMED, AND NO ADDITIONAL INFORMATION WAS RECEIVED.

    Description of Event or Problem · 0

    THE CONSUMER REPORTED A FALSE NEGATIVE RESULT WITH THE BINAXNOW COVID-19 AG SELF TEST PERFORMED ON AN UNKNOWN DATE. THE CONSUMER REPORTED HAVING BEEN SYMPTOMATIC WITH LOSS OF TASTE AND A POSSIBLE SINUS INFECTION. NO ADDITIONAL TESTING WAS PERFORMED, AND NO ADDITIONAL INFORMATION WAS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2855229 BINAXNOW COVID-19 AG SELF TEST 2CT CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. QYT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 000905503A 00811877011408

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Male