BEUDAMED
    FDA Enforcement Class II Terminated

    Separation Technology Creamatocrit Plus, Catalog Number: 100-146

    Recall: Z-0905-2022 · Reported April 20, 2022

    Enforcement

    Recall Number
    Z-0905-2022
    Event ID
    89829
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Stanbio Laboratory, LP
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 20, 2022
    Initiation Date
    March 16, 2022
    Classification Date
    April 11, 2022
    Termination Date
    January 2, 2025
    Address
    1261 N Main St, N/A, Boerne, TX, 78006-3014, United States

    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)

    Code Info

    Sold between 2019 and 2021

    Distribution

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

    Quantity

    50