BEUDAMED
    FDA Recall Terminated

    Dimension(R) IRON Calibrator (DC85), Siemens material number 10445010. The Dimension(R) IRON Calibrator is an in vitro diagnostic product intended to be used to calibrate the Iron method for the Dimension(R) clinical chemistry system.

    Recall: Z-0745-2013 · Initiated December 20, 2012

    Recall

    Recall Number
    Z-0745-2013
    Event Number
    64081
    Firm
    Siemens Healthcare Diagnostics, Inc.
    FEI Number
    2517506
    Product Code
    JIS
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    December 20, 2012
    Posted
    January 29, 2013
    Terminated
    January 8, 2014
    Address
    500 Gbc Dr PO BOX 6101, Ms 514, Newark, DE, 19702-2466

    Description

    Dimension(R) IRON Calibrator (DC85), Siemens material number 10445010. The Dimension(R) IRON Calibrator is an in vitro diagnostic product intended to be used to calibrate the Iron method for the Dimension(R) clinical chemistry system.

    Reason

    Siemens Healthcare Diagnostics has received complaints of IRON calibrations outside of acceptable calibration slope (m) values (0.97 - 1.03) when using IRON calibrator lots 2DN060 and 2FN063. Lots 2GN068 and 2JN074 may also be impacted but no complaints have been received.

    Action

    Siemens sent a "CUSTOMER NOTIFICATION" letter dated December 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Contact Siemens Technical Solutions Center at 1-800-441-9250 or your local Siemens Healthcare Diagnostics representative for assistance with this issue.

    Distribution

    Nationwide Distribution.

    Quantity

    5999