BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BINAXNOW MALARIA 25T US

    MDR report key: 24688115 · Received March 25, 2026

    Report

    Report Number
    1221359-2026-00036
    Event Type
    Malfunction
    Date Received
    March 25, 2026
    Date of Event
    February 22, 2026
    Report Date
    March 25, 2026
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    OAX
    UDI-DI
    10811877010378
    PMA / PMN Number
    K061542
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    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.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THREE (3) FALSE NEGATIVE RESULTS OBTAINED WITH BINAXNOW MALARIA TESTS ON A SINGLE PATIENT ACROSS MULTIPLE TESTING DATES. THIS MANUFACTURER REPORT PERTAINS TO TEST ONE (1) OF THE THREE (3) TESTS. THE CUSTOMER REPORTED A FALSE NEGATIVE RESULT WITH THE BINAXNOW MALARIA TEST PERFORMED ON (B)(6) 2026 ON A WHOLE BLOOD SAMPLE. SUBSEQUENT CONFIRMATION TESTING WAS CONDUCTED VIA MICROSCOPY AND PCR ON WHOLE BLOOD SAMPLES ON (B)(6) 2026, BOTH OF WHICH YIELDED POSITIVE RESULTS. ACCORDING TO THE CUSTOMER, THE DELAYED DETECTION OF MALARIA RESULTED IN DELAYED IDENTIFICATION OF THE INFECTION, AND TREATMENT FOR A POSSIBLE PLASMODIUM OVALE/VIVAX INFECTION WAS INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    750301 BINAXNOW MALARIA 25T US PLASMODIUM SPP. DETECTION REAGENTS OAX ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 0000914228 10811877010378

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown