BEUDAMED
    FDA Enforcement Class II Ongoing

    DiaSorin LIAISON HSV-2 Type Specific IgG, REF 310620

    Recall: Z-0815-2024 · Reported January 31, 2024

    Enforcement

    Recall Number
    Z-0815-2024
    Event ID
    93741
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Diasorin Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    January 31, 2024
    Initiation Date
    December 13, 2023
    Classification Date
    January 25, 2024
    Address
    1951 Northwestern Ave S, N/A, Stillwater, MN, 55082-7536, United States

    Description

    DiaSorin LIAISON HSV-2 Type Specific IgG, REF 310620

    Reason

    DiaSorin has identified that lots 136344, 136344A, 136344B, 136344C, 136520, 136520A, 136520B, 136520C, 136604, 136703, 136703A, 136703B, 136703C 136775of LIAISON HSV-2 Type Specific IgG assay may produce increased equivocal and/or false positive results.

    Code Info

    UDI/DI 08056771600101, Lot Numbers: 136344, 136344A, 136344B, 136344C, 136520, 136520A, 136520B, 136520C, 136604, 136703, 136703A, 136703B, 136703C, 136775

    Distribution

    Worldwide distribution - US Nationwide and the country of Canada.

    Quantity

    31992 units