BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BINAX NOW COVID-19 AG CARD KIT 40T EUA

    MDR report key: 25178059 · Received May 14, 2026

    Report

    Report Number
    1221359-2026-00165
    Event Type
    Malfunction
    Date Received
    May 14, 2026
    Date of Event
    April 22, 2026
    Report Date
    May 14, 2026
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    QYT
    UDI-DI
    10811877011290
    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

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

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED TWO (2) FALSE POSITIVE RESULTS WITH TWO (2) PATIENTS WITH THE BINAXNOW COVID-19 AG TEST TAKEN ON (B)(6) 2026. THE REPORT IS FOR TEST 1 WITH PATIENT 1. THE CUSTOMER REPORTED A FALSE POSITIVE RESULT WITH THE BINAXNOW COVID-19 AG TEST TAKEN ON (B)(6) 2026. A PCR TEST RETURNED NEGATIVE RESULTS. ALTHOUGH REQUESTED, NO ADDITIONAL INFORMATION INCLUDING TREATMENT OR OUTCOME WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    548479 BINAX NOW COVID-19 AG CARD KIT 40T EUA CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. QYT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 00996155BY 10811877011290

    Patients

    Seq Age Sex Outcome Treatment
    1 16 DA Unknown