BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOKIT HSV 2 TEST

    MDR report key: 16495878 · Received March 6, 2023

    Report

    Report Number
    MW5115471
    Event Type
    Malfunction
    Date Received
    March 6, 2023
    Report Date
    March 2, 2023
    Manufacturer
    BIOKIT S.A.
    Product Code
    MYF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OR, US
    Reporter Occupation
    117
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    FALSE POSITIVE HSV 2 ANTIBODY TESTS COMPARED TO THE HERPES WESTERN BLOT GOLD STANDARD. BIOKIT HSV 2 TEST ALSO POSITIVE. REFERENCE REPORT: MW5115470.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    659816 BIOKIT HSV 2 TEST ENZYME LINKED IMMUNOSORBENT ASSAY, HERPES SIMPLEX VIRUS, HSV-2 MYF BIOKIT S.A.

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Male Other