BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIASORIN LIASON XL HSV 1 TYPE SPECIFIC ANTIBODY TEST

    MDR report key: 16643721 · Received March 29, 2023

    Report

    Report Number
    MW5116086
    Event Type
    Injury
    Date Received
    March 29, 2023
    Date of Event
    June 20, 2022
    Report Date
    March 27, 2023
    Manufacturer
    DIASORIN, INC.
    Product Code
    MXJ
    Adverse Event
    Yes
    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 1 AND 2 ANTIBODY TESTS COMPARED TO THE HERPES WESTERN BLOT GOLD STANDARD. REFERENCE REPORT: MW5116087.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    392783 DIASORIN LIASON XL HSV 1 TYPE SPECIFIC ANTIBODY TEST ENZYME LINKED IMMUNOSORBENT ASSAY, HERPES SIMPLEX VIRUS, HSV-1 MXJ DIASORIN, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Female Other