BEUDAMED
    FDA Recall Open, Classified

    Simplexa Direct Amplification Disc Kit, Product Kit Code MOL1455

    Recall: Z-0457-2022 · Initiated November 19, 2021

    Recall

    Recall Number
    Z-0457-2022
    Event Number
    89098
    Firm
    DiaSorin Molecular LLC
    FEI Number
    2023365
    Product Code
    OOI
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    November 19, 2021
    Address
    11331 Valley View St, Cypress, CA, 90630-5366

    Description

    Simplexa Direct Amplification Disc Kit, Product Kit Code MOL1455

    Reason

    A subset of affected discs are at risk of leakage when it is used more than one time with Simplexa COVID-19 Direct and/or Simplexa Flu A/B & RSV Direct Gen II. Leakage from a well that had a positive sample may cause further cross-contamination in areas of the lab if not properly cleaned.

    Action

    On 11/19/2021, the firm notified affected customers via email of "URGENT: MEDICAL DEVICE CORRECTION NOTIFICATION." The letter indicated, "Actions to be taken by the Customer/User/Distributor: - Any remaining discs in inventory that are listed in the table below should only be used one time and not reused. - Any sample with an error code should be retested. - If leakage is suspected, the spillage should be removed and the instrument surface should be decontaminated. Ensure the practice of Good Laboratory Procedures including regular cleaning. - Notify others within your network that may have received these kits. - Complete and return the Acknowledgement and Receipt Form (page 3) of this notification letter. - 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 to us. If you have any questions or if you would like replacement product for the Direct Amplification Discs you still have in stock, please contact DiaSorin Molecular Technical Service, Monday Friday, 7:00am to 5:00pm (Pacific Time) at (800) 838-4548, option 3, or by email at [email protected]."

    Distribution

    US: AZ, CA, CO, CT, DC, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, NC, ND, NE, NH, NJ, NM, NV, NY, OH, PA, RI, SC, SD, TN, TX, VA, VT, WA, WI, WV; and Worldwide: Kuwait, Australia, Israel, Italy, Canada, Chile, Puerto Rico, United Arab Emirates.

    Quantity

    29495 kits