BEUDAMED
    FDA Enforcement Class II Ongoing

    SIMPLEXA COVID-19 Positive Control Pack, REF MOL4160, IVD, Rx Only, UDI: (01) 20816101027051

    Recall: Z-0162-2022 · Reported October 27, 2021

    Enforcement

    Recall Number
    Z-0162-2022
    Event ID
    88825
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    DiaSorin Molecular LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    October 27, 2021
    Initiation Date
    September 23, 2021
    Classification Date
    October 21, 2021
    Address
    11331 Valley View St, N/A, Cypress, CA, 90630-5366, United States

    Description

    SIMPLEXA COVID-19 Positive Control Pack, REF MOL4160, IVD, Rx Only, UDI: (01) 20816101027051

    Reason

    Due to unapproved raw materials used in the manufacturing of Covid-19 control pack, their is the potential for delayed amplification signals.

    Code Info

    Lot #/Expiration Date: 12175N/11.30.2021, 12722N/01.31.2022, X12122N/01.31.2022, X12724N/08.31.2022

    Distribution

    Worldwide distribution - US Nationwide distribution in the states of AL, AZ, CA, CO, DE, FL, GA, IL, IN, KS, KY, MA, MD, ME, MI, MN, MO, NC, ND, NE, NJ, NV, NY, OH, OK, PA, SD, TN, TX, VA, VT, WA, WI, WV and the countries of Canada, Italy.

    Quantity

    1690 kits