BEUDAMED
    FDA Enforcement Class II Terminated

    MOL3655 Simplexa VZV Swab Direct - Product Usage: is intended for use on the LIAISON MDX instrument for the qualitative detection of varicella-zoster virus (VZV) DNA present in cutaneous and mucocutaneous lesion swabs from patients with signs and symptoms of VZV infection.

    Recall: Z-2549-2020 · Reported July 22, 2020

    Enforcement

    Recall Number
    Z-2549-2020
    Event ID
    85744
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    DiaSorin Molecular LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    July 22, 2020
    Initiation Date
    May 12, 2020
    Classification Date
    July 10, 2020
    Termination Date
    April 19, 2024
    Address
    11331 Valley View St, N/A, Cypress, CA, 90630-5366, United States

    Description

    MOL3655 Simplexa VZV Swab Direct - Product Usage: is intended for use on the LIAISON MDX instrument for the qualitative detection of varicella-zoster virus (VZV) DNA present in cutaneous and mucocutaneous lesion swabs from patients with signs and symptoms of VZV infection.

    Reason

    Due to a software malfunction in the Multi Assay Suite, there is the probability of increased occurrence of false negative results.

    Code Info

    MOL3655 Simplexa VZV Swab Direct: Lot Numbers Release Date Exp Date 5743N 09/11/19 9/30/2020 5819N 10/09/19 10/31/2020 5820N 02/14/20 2/28/2021

    Distribution

    Worldwide distribution - U.S. Nationwide distribution including in the states of CO, FL, KS, MI, NC, PA, TX, and WA The countries of Austria, Czech Republic, France and Switerland.

    Quantity

    304 plastic vials (24 vials per box)