BEUDAMED
    FDA Adverse Event Other Summary report: N

    DPC IMMULITE H PYLORI IGG

    MDR report key: 331692 · Received May 8, 2001

    Report

    Report Number
    MW1021839
    Event Type
    Other
    Date Received
    May 8, 2001
    Date of Event
    October 1, 2000
    Report Date
    May 1, 2001
    Manufacturer
    DIAGNOSTIC PRODUCTS CORP
    Product Code
    KTO
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    FALSE POSITIVE SEROLOGIC RESULTS FOR HELICOBACTER PYLORI IGG. MFR INDICATES OTHER LOTS AFFECTED FOR ANOTHER INSTRUMENT (IMMULITE 2000).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    21000 DPC IMMULITE H PYLORI IGG DIAGNOSTIC KITS KTO DIAGNOSTIC PRODUCTS CORP * *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other