BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BINAXNOW MALARIA 25T OUS

    MDR report key: 24045152 · Received January 12, 2026

    Report

    Report Number
    1221359-2026-00007
    Event Type
    Malfunction
    Date Received
    January 12, 2026
    Date of Event
    December 16, 2025
    Report Date
    April 14, 2026
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    OAX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G4: THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 660-000 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 665-025. THE INVESTIGATION IS ONGOING; A SUPPLEMENT REPORT WILL BE SUBMITTING UPON COMPLETION.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED TWO (2) FALSE NEGATIVE RESULTS WITH THE BINAXNOW MALARIA TEST ON TWO (2) PATIENTS ON UNKNOWN DATES USING K3EDTA BLOOD IN 2.7ML MONOVETTES FROM SARSTEDT, WHICH WAS PREPARED IMMEDIATELY UPON RECEIPT. THIS IS REPORT ONE (1) OF TWO (2) THE CUSTOMER INDICATED THAT BOTH PATIENTS TESTED NEGATIVE FOR P. FALCIPARUM AND WERE SYMPTOMATIC. THE CUSTOMER REPORTED THAT NEW SAMPLES WERE TAKEN FROM THE PATIENTS AND MICROSCOPICALLY EXAMINED PER FACILITY PROTOCOL WHICH SHOWED A POSITIVE RESULT FOR P. FALCIPARUM. THERE WAS NO REPORT OF PATIENT IMPACT AS A RESULT. THE CUSTOMER ALSO REPORTED THAT THEY HAVE SEEN AN INCREASE IN THE HIGH-DOSE HOOK EFFECT IN THE P. FALCIPARUM BAND. NO ADDITIONAL INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    105992 BINAXNOW MALARIA 25T OUS PLASMODIUM SPP. DETECTION REAGENTS OAX ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 0000945458

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown