BEUDAMED
    FDA Recall Open, Classified

    DiaSorin LIAISON HSV-2 Type Specific IgG, REF 310620

    Recall: Z-0815-2024 · Initiated December 13, 2023

    Recall

    Recall Number
    Z-0815-2024
    Event Number
    93741
    Firm
    Diasorin Inc.
    FEI Number
    2182595
    Product Code
    MYF
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    December 13, 2023
    Posted
    January 25, 2024
    Address
    1951 Northwestern Ave S, Stillwater, MN, 55082-7536

    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.

    Action

    DiaSorin issued a DIASORIN CUSTOMER NOTIFICATION LETTER to its consignees on 12/13/2023 via email. The notice explained the issue, risk to health, and requested the disposal of all affected inventory. The firm will be providing replacement kits.

    Distribution

    Worldwide distribution - US Nationwide and the country of Canada.

    Quantity

    31992 units