BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HCG/QUAL

    MDR report key: 24002943 · Received January 8, 2026

    Report

    Report Number
    24002943
    Event Type
    Malfunction
    Date Received
    January 8, 2026
    Date of Event
    September 1, 2025
    Report Date
    December 18, 2025
    Manufacturer
    SEKISUI DIAGNOSTICS, LLC
    Product Code
    JJX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO
    Reporter Occupation
    501

    Narratives

    Description of Event or Problem · 0

    MULTIPLE INSTANCES OF HCG/QUAL TEST RETURNING A FALSE POSITIVE RESULT. FURTHER TESTING RESULTS IN NEGATIVE HCG/QUAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    62320 HCG/QUAL SINGLE (SPECIFIED) ANALYTE CONTROLS (ASSAYED AND UNASSAYED) JJX SEKISUI DIAGNOSTICS, LLC 565E13

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Female