BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EBV IGM KIT

    MDR report key: 35044 · Received August 7, 1996

    Report

    Report Number
    MW1009661
    Event Type
    Malfunction
    Date Received
    August 7, 1996
    Date of Event
    June 1, 1996
    Report Date
    August 5, 1996
    Manufacturer
    GULL LABORATORIES, INC.
    Product Code
    JRY
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    SEROLOGIC TESTING USING EPSTEIN-BARR VIRUS IGM KIT HAS YIELDED APPARENT FALSE POSITIVE RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EBV IGM KIT DIAGNOSTIC REAGENT FOR EPSTEIN-BARR JRY GULL LABORATORIES, INC. 6CLBXR

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other