BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BINAXNOW COVID-19 AG SELF TEST 2CT

    MDR report key: 23194118 · Received October 1, 2025

    Report

    Report Number
    1221359-2025-00408
    Event Type
    Malfunction
    Date Received
    October 1, 2025
    Date of Event
    September 26, 2025
    Report Date
    December 19, 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

    TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 000913267A 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: 000913267A, TEST BASE PART NUMBER 195-430WJR/LOT: 913267. 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 000913267 SHOWED THAT THE COMPLAINT RATE IS (B)(4). ABBOTT DIAGNOSTICS SCARBOROUGH, INC. WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    THE CONSUMER REPORTED A FALSE NEGATIVE RESULT WITH THE BINAXNOW COVID-19 AG SELF TEST PERFORMED ON (B)(6) 2025 WITH A NASAL SAMPLE. THE CONSUMER INDICATED THAT THEIR SPOUSE RECEIVED A POSITIVE RESULT ON (B)(6) 2025, ON A DIFFERENT TEST (UNKNOWN BRAND). ON (B)(6) 2025, THE CUSTOMER TESTED NEGATIVE WITH THE BINAXNOW COVID-19 AG SELF-TEST. PER THE CUSTOMER, THEIR SPOUSE HAS COVID. ALTHOUGH REQUESTED, NO ADDITIONAL CONSUMER INFORMATION WAS REPORTED.

    Description of Event or Problem · 0

    THE CONSUMER REPORTED A FALSE NEGATIVE RESULT WITH THE BINAXNOW COVID-19 AG SELF TEST PERFORMED ON (B)(6) 2025 WITH A NASAL SAMPLE. THE CONSUMER INDICATED THAT THEIR SPOUSE RECEIVED A POSITIVE RESULT ON (B)(6), 2025, ON A DIFFERENT TEST (UNKNOWN BRAND). ON (B)(6), 2025, THE CUSTOMER TESTED NEGATIVE WITH THE BINAXNOW COVID-19 AG SELF-TEST. PER THE CUSTOMER, THEIR SPOUSE HAS COVID. ALTHOUGH REQUESTED, NO ADDITIONAL CONSUMER INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2014716 BINAXNOW COVID-19 AG SELF TEST 2CT CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. QYT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 000913267A 00811877011408

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown