BEUDAMED
    FDA Enforcement Class II Terminated

    MOL3650 Simplexa VZV Direct - Product Usage: is intended for use on the LIAISON MDX instrument for the qualitative detection of varicella-zoster virus (VZV) DNA in cerebrospinal fluid (CSF) from patients with signs and symptoms of VZV infections of the central nervous system (CNS).

    Recall: Z-2548-2020 · Reported July 22, 2020

    Enforcement

    Recall Number
    Z-2548-2020
    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

    MOL3650 Simplexa VZV Direct - Product Usage: is intended for use on the LIAISON MDX instrument for the qualitative detection of varicella-zoster virus (VZV) DNA in cerebrospinal fluid (CSF) from patients with signs and symptoms of VZV infections of the central nervous system (CNS).

    Reason

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

    Code Info

    MOL3650 Simplexa VZV Direct: Lot Numbers Release Date Exp Date 5178N 06/12/19 6/30/2020 7004N 03/04/20 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

    405 plastic vials (24 vials per box)