BEUDAMED
    FDA Recall Terminated

    The Enzyme II Calibrator is an in vitro diagnostic product for the Alanine Aminotransferase (ALTI) on the Dimension clinical chemistry system. For prescription use only.

    Recall: Z-1217-2017 · Initiated May 5, 2016

    Recall

    Recall Number
    Z-1217-2017
    Event Number
    76293
    Firm
    Siemens Healthcare Diagnostics, Inc.
    FEI Number
    2517506
    Product Code
    JIT
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    May 5, 2016
    Terminated
    February 2, 2018
    Address
    500 Gbc Dr PO BOX 6101, Ms 514, Newark, DE, 19702-2466

    Description

    The Enzyme II Calibrator is an in vitro diagnostic product for the Alanine Aminotransferase (ALTI) on the Dimension clinical chemistry system. For prescription use only.

    Reason

    Complaints of positive shift of patient and QC results when the ALTI assay is calibrated with the Dimension Enzyme II calibrator. Internal investigation has confirmed that patient samples and QC material demonstrate a shift of up to 10% in comparison to results obtained using earlier calibrator lots.

    Action

    Siemens mailed an Urgent Medical Device Notification letter to all affected customers on May 10, 2016. The notice provided information on actions to be taken by the customer to work around the issue. For further questions, please call (800) 441-9250.

    Distribution

    Distributed throughout the United States

    Quantity

    24,940.00