BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BINAXNOW COVID-19 AG SELF TEST 4CT

    MDR report key: 24046283 · Received January 12, 2026

    Report

    Report Number
    1221359-2026-00009
    Event Type
    Malfunction
    Date Received
    January 12, 2026
    Date of Event
    January 3, 2026
    Report Date
    January 29, 2026
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    QYT
    UDI-DI
    00811877011729
    PMA / PMN Number
    K243518
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE REMAINDER OF THE INVESTIGATION IS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED PENDING COMPLETION, OR UPON RECEIPT OF NEW INFORMATION.

    Additional Manufacturer Narrative · 0

    TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 000913270A 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 195-180/LOT: 000913270A, TEST BASE PART NUMBER 195-430WJR/ LOT: 913270. 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 000913270A 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 CONSUMER REPORTED TWO (2) FALSE NEGATIVE RESULTS OBTAINED WITH THE BINAXNOW COVID 19 AG SELF TESTS PERFORMED ON (B)(6) 2026. THIS MANUFACTURER REPORT ADDRESSES TEST ONE (1) OF THE TWO (2) TESTS ADMINISTERED BY THE USER. THE CONSUMER REPORTED A FALSE NEGATIVE RESULT WITH THE BINAXNOW COVID 19 AG SELF TEST PERFORMED ON (B)(6) 2026 USING AN UNKNOWN SAMPLE TYPE. THE CONSUMER PREVIOUSLY TESTED WITH A DIFFERENT BRAND OF TEST (BRAND UNKNOWN) ON (B)(6) 2025, WHICH YIELDED A POSITIVE RESULT. NO CONFIRMATION TESTING WAS CONDUCTED. THE CONSUMER REPORTED EXPERIENCING A HEADACHE AS A SYMPTOM. THE CUSTOMER CONFIRMED THERE WAS NO PATIENT HARM DUE TO THE TEST RESULTS.

    Description of Event or Problem · 0

    THE CONSUMER REPORTED TWO (2) FALSE NEGATIVE RESULTS OBTAINED WITH THE BINAXNOW COVID 19 AG SELF TESTS PERFORMED ON (B)(6) 2026. THIS MANUFACTURER REPORT ADDRESSES TEST ONE (1) OF THE TWO (2) TESTS ADMINISTERED BY THE USER. THE CONSUMER REPORTED A FALSE NEGATIVE RESULT WITH THE BINAXNOW COVID 19 AG SELF TEST PERFORMED ON (B)(6) 2026 USING AN UNKNOWN SAMPLE TYPE. THE CONSUMER PREVIOUSLY TESTED WITH A DIFFERENT BRAND OF TEST (BRAND UNKNOWN) ON (B)(6) 2025, WHICH YIELDED A POSITIVE RESULT. NO CONFIRMATION TESTING WAS CONDUCTED. THE CONSUMER REPORTED EXPERIENCING A HEADACHE AS A SYMPTOM. THE CUSTOMER CONFIRMED THERE WAS NO PATIENT HARM DUE TO THE TEST RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    107218 BINAXNOW COVID-19 AG SELF TEST 4CT CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. QYT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 000913270A 00811877011729

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Female