BEUDAMED
    FDA Enforcement Class II Terminated

    Dimension Vista Protein 1 Control M, PROT 1 CON M, Siemens Material Number (SMN) 10445920, Product Code KC716; IVD

    Recall: Z-0175-2018 · Reported December 6, 2017

    Enforcement

    Recall Number
    Z-0175-2018
    Event ID
    77381
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Siemens Healthcare Diagnostics, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 6, 2017
    Initiation Date
    May 23, 2017
    Classification Date
    November 28, 2017
    Termination Date
    March 30, 2018
    Address
    500 Gbc Dr Ms 514, PO BOX 6101, Newark, DE, 19702-2466, United States

    Description

    Dimension Vista Protein 1 Control M, PROT 1 CON M, Siemens Material Number (SMN) 10445920, Product Code KC716; IVD

    Reason

    Complaint of high amount of ceruloplasmin patient results below the reference range (< 20 mg/dL [0.2 g/L]. PROT1 CAL and corresponding PROT1 CON L, M, and H are inaccurately assigned for ceruloplasmin (CER).

    Code Info

    Lot numbers: 6BQM01, 6BQM01A, 6BQM01B, 6BQM01C,6BQM01D, 6BQM01E (exp. date 2017-06-17); 6FQM01, 6FQM01A (exp. date 2017-11-03) --- Lot # (UDI): 6BQM01 (008427680063336JQL01C20180131), 6BQM01A (008427680063406BQM01A20170617), 6BQM01B (008427680063406BQM01B20170617), 6BQM01C (008427680063406BQM01C20170617), 6BQM01D( 008427680063406BQM01D20170617), 6BQM01E (008427680063406BQM01E20170617), 6FQM01(008427680063406FQM0120171103), 6FQM01A (008427680063406FQM01A20171103).

    Distribution

    Worldwide Distribution - US (nationwide) Internationally to Austria, Australia, Belgium, Canada, France, Germany, Great Britain, Italy, Japan, Netherlands, Portugal, Slovakia, Spain, Switzerland and Republic of Korea South

    Quantity

    N/A