BEUDAMED
    FDA Enforcement Class II Terminated

    Dimension Vista Myoglobin Calibrator (MYO CAL), Lot 4FD085 Product usage: in vitro diagnostic product for the calibration of Myoglobin (MYO) method on the Dimension Vista System.

    Recall: Z-0946-2015 · Reported January 14, 2015

    Enforcement

    Recall Number
    Z-0946-2015
    Event ID
    69937
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Siemens Healthcare Diagnostics, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 14, 2015
    Initiation Date
    November 24, 2014
    Classification Date
    January 8, 2015
    Termination Date
    December 13, 2016
    Address
    500 Gbc Dr Ms 514, PO BOX 6101, Newark, DE, 19702-2466, United States

    Description

    Dimension Vista Myoglobin Calibrator (MYO CAL), Lot 4FD085 Product usage: in vitro diagnostic product for the calibration of Myoglobin (MYO) method on the Dimension Vista System.

    Reason

    Dimension Vista Myoglobin Calibrator (MYO CAL) may produce a positive shift in MYO QC and Patient test results that exceeds acceptance criteria for this product. A positive shift observed up to 12% at MYO concentrations within and above the reference range of the assay. Depending on quality control limits, this drift may not be detected.

    Code Info

    Lot 4FD085, exp. 12-01-2014

    Distribution

    Worldwide Distribution: US (nationwide) and country of: Canada.

    Quantity

    1230