BEUDAMED
    FDA Recall Open, Classified

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

    Recall: Z-0162-2022 · Initiated September 23, 2021

    Recall

    Recall Number
    Z-0162-2022
    Event Number
    88825
    Firm
    DiaSorin Molecular LLC
    FEI Number
    2023365
    Product Code
    QJR
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    September 23, 2021
    Address
    11331 Valley View St, Cypress, CA, 90630-5366

    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.

    Action

    On September 23, 2021, DiaSorin Molecular issued a field courtesy notification letter via email. On October 18, 2021, DiaSorin issued a "Urgent: Medical Device Correction" notification to provide additional details concerning the recall. In addition to informing consignees about the correction, DiaSorin asked consignees to take the following actions: 1. A run with a failed positive control should be repeated per the IFU instructions. 2. Please be sure to notify others within your network that may have received these kits. 3. Please complete and return the Acknowledgement and Receipt Form (page 2) of this notification letter. 4. If your firm has further distributed the devices, please share a copy of this correction notification and response form with those customers and provide a copy of the completed response form back us. 5. If you have any questions or if you have experienced an invalid Positive Control run and would like replacement product for the tests that were invalid due to this, please contact DiaSorin Molecular Technical Service, Mon-Fri, 7:00 AM to 5:00 PM (Pacific Time) at (800) 838-4548, option 3, or by email at [email protected]. 6. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

    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