BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BINAX NOW COVID-19 AG CARD KIT 40T EUA

    MDR report key: 25178055 · Received May 14, 2026

    Report

    Report Number
    1221359-2026-00171
    Event Type
    Malfunction
    Date Received
    May 14, 2026
    Date of Event
    April 1, 2026
    Report Date
    May 14, 2026
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    QYT
    PMA / PMN Number
    K243518
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B5 - THE CUSTOMER DID NOT PROVIDE ANY PRODUCT INFORMATION OR TEST DATE FOR THE PREVIOUS FALSE POSITIVE TEST. THIS REPORT IS BEING SENT OUT OF AN ABUNDANCE OF CAUTION. THE INVESTIGATION REMAINS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THREE (3) FALSE POSITIVE RESULTS FROM PREVIOUS TESTING WITH THE BINAXNOW COVID-19 AG TEST KIT TAKEN ON UNKNOWN DATES. THIS REPORT IS FOR TEST ONE (1) OF THREE (3). IT IS UNKNOWN IF CONFIRMATORY TESTING WAS PERFORMED AT THE TIME OF THE PREVIOUS TESTS. HOWEVER, RECENT PCR TESTING RETURNED A NEGATIVE RESULT. ALTHOUGH REQUESTED, NO ADDITIONAL INFORMATION INCLUDING TREATMENT OR OUTCOME WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    378515 BINAX NOW COVID-19 AG CARD KIT 40T EUA CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. QYT ABBOTT DIAGNOSTICS SCARBOROUGH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male