BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BINAXNOW COVID-19 AG SELF TEST 2CT

    MDR report key: 23634626 · Received November 24, 2025

    Report

    Report Number
    1221359-2025-00842
    Event Type
    Malfunction
    Date Received
    November 24, 2025
    Date of Event
    November 15, 2025
    Report Date
    January 14, 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
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 0000916289 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: 0000916289, TEST BASE PART NUMBER 195-430WJR/LOT: 916289. 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 0000916289 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 HAVE POSSIBLY BEEN RELATED TO THE SPECIFIC PATIENT SAMPLES.

    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.

    Description of Event or Problem · 0

    THE CONSUMER REPORTED RECEIVING A FALSE NEGATIVE RESULT USING THE BINAXNOW COVID-19 AG SELF-TEST ON (B)(6) 2025. INITIAL TESTING WAS CONDUCTED ON (B)(6) 2025 AND (B)(6) 2025 USING INTELLSWAB RAPID TESTS, BOTH YIELDING NEGATIVE RESULTS. TWO ADDITIONAL TESTS WERE PERFORMED USING INTELLSWAB RAPID TESTS ON (B)(6) 2025, BOTH OF WHICH PRODUCED POSITIVE RESULTS. CONFIRMATION TESTING WAS PERFORMED ON AN UNKNOWN DATE WITH UNKNOWN TEST BRAND WHICH GENERATED NEGATIVE RESULT. THE CONSUMER REPORTED EXPERIENCING SYMPTOMS INCLUDING BODY ACHES, RUNNY NOSE, AND COUGH AT THE TIME OF TESTING. THE CONSUMER INDICATED INITIATING PAXLOVID TREATMENT ON (B)(6) 2025, CONTINUING THROUGH (B)(6) 2025. THE CONSUMER CONFIRMED THAT THEY ARE NOW FEELING BETTER.

    Description of Event or Problem · 0

    THE CONSUMER REPORTED RECEIVING A FALSE NEGATIVE RESULT USING THE BINAXNOW COVID-19 AG SELF-TEST ON (B)(6) 2025. INITIAL TESTING WAS CONDUCTED ON (B)(6) 2025 USING INTELLSWAB RAPID TESTS, BOTH YIELDING NEGATIVE RESULTS. TWO ADDITIONAL TESTS WERE PERFORMED USING INTELLSWAB RAPID TESTS ON (B)(6) 2025, BOTH OF WHICH PRODUCED POSITIVE RESULTS. CONFIRMATION TESTING WAS PERFORMED ON AN UNKNOWN DATE WITH UNKNOWN TEST BRAND WHICH GENERATED NEGATIVE RESULT. THE CONSUMER REPORTED EXPERIENCING SYMPTOMS INCLUDING BODY ACHES, RUNNY NOSE, AND COUGH AT THE TIME OF TESTING. THE CONSUMER INDICATED INITIATING PAXLOVID TREATMENT ON (B)(6) 2025, CONTINUING THROUGH (B)(6) 2025. THE CONSUMER CONFIRMED THAT THEY ARE NOW FEELING BETTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2340963 BINAXNOW COVID-19 AG SELF TEST 2CT CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. QYT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 0000916289 00811877011408

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown