BEUDAMED
    FDA Enforcement Class II Terminated

    N Cuvette Segments for BN ProSpec System-IVD a system for the quantitative determination of proteins in serum, plasma, urine and CSF. Siemens Material Number (SMN):10446539

    Recall: Z-2341-2019 · Reported August 28, 2019

    Enforcement

    Recall Number
    Z-2341-2019
    Event ID
    83311
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Siemens Healthcare Diagnostics, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 28, 2019
    Initiation Date
    June 27, 2019
    Classification Date
    August 22, 2019
    Termination Date
    May 27, 2020
    Address
    511 Benedict Ave, N/A, Tarrytown, NY, 10591-5005, United States

    Description

    N Cuvette Segments for BN ProSpec System-IVD a system for the quantitative determination of proteins in serum, plasma, urine and CSF. Siemens Material Number (SMN):10446539

    Reason

    Iincreased (falsely elevated) Albumin results compared to expected results

    Code Info

    Lot # 5890128326 and Lot # 182670004 UDI: 00842768012334

    Distribution

    Nationwide

    Quantity

    664 units