BEUDAMED
    FDA Recall Terminated

    Separation Technology Creamatocrit Plus, Catalog Number: 100-146

    Recall: Z-0905-2022 · Initiated March 16, 2022

    Recall

    Recall Number
    Z-0905-2022
    Event Number
    89829
    FEI Number
    1616487
    Product Code
    QEI
    Status
    Terminated
    Root Cause
    No Marketing Application
    Initiated
    March 16, 2022
    Terminated
    January 2, 2025
    Address
    1261 N Main St, Stanbio Laboratory, LP, Boerne, TX, 78006-3014

    Description

    Separation Technology Creamatocrit Plus, Catalog Number: 100-146

    Reason

    The device was being marketed as an IVD without a 510(k). Therefore, performance characteristics of these breast milk analyzers have not been adequately validated. An erroneous result could lead to sub-optimal nutrition supplementation for patients (infants)

    Action

    On 03/16/22, recall notices were mailed to customers who were asked to take the following actions: Stop using the affected device while you review the new Research Use Only labeling included with this letter. If you are using the affected device for research use only, then apply/use the new labeling. If you are using the affected human breast milk analyzer to provide information relating to the nutritional management of infants, then destroy the product in accordance with local regulations. If the affected product was further distributed or forwarded elsewhere, then forward this recall notice to all that need to be aware; alternately, provide a customer contact list so the recalling firm can send this recall notice to these customers. Please complete the Recall Return Response form to the recalling firm. Customers with additional questions are asked to contact Technical Support, Monday through Friday, 8:00 AM to 5:00 PM, Central Time at 1-800-531-5535 or via email at [email protected].

    Distribution

    US Nationwide Distribution CA, TX, OK, SD, IL, NV, MO, FL, WA, KY, WI, PA, NC, GA, MD, MN

    Quantity

    50