BEUDAMED
    FDA Recall 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 · Initiated May 12, 2020

    Recall

    Recall Number
    Z-2549-2020
    Event Number
    85744
    Firm
    DiaSorin Molecular LLC
    FEI Number
    2023365
    Product Code
    PGI
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    May 12, 2020
    Posted
    July 10, 2020
    Terminated
    April 19, 2024
    Address
    11331 Valley View St, Cypress, CA, 90630-5366

    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.

    Action

    On 05/12/2020, the firm sent an "URGENT FIELD SAFETY NOTIFICATION LETTER" with an acknowledgement form to customers and distributors via email to inform them of an internal observed issue associated with the use of their Multi-Assay Suite (MAS) featured in the software version 2.0 where it may incorrectly apply the thresholds of the first loaded assay to the analytes coupled with the same dye in the second assay resulting in false negative or false positive results. The firm is instructing customers to: -Immediately discontinue the use of the MAS feature and that the issue will be correct in the new Software Version 2.1 which is expected to be release in June 2020. -Fill out the Response Form and return by either: -fax (562) 240-6526 Attention: Technical Services -email to: technical [email protected] -mail to: ATTN: Technical Services, 11331 Valley View Street, Cypress, CA 90630 -Forward this communication to all required individuals with their organization. For further assistance with evaluating assay runs or for any questions, to contact Technical Services at +1-5672-240-6500, option 3 or via email [email protected]

    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)