BEUDAMED
    FDA Recall Terminated

    Siemens Healthcare Diagnostics, Dimension Vista(R) Cardiac Troponin I Calibrator (KC678) lot 1DD085, in vitro diagnostic

    Recall: Z-0513-2012 · Initiated November 17, 2011

    Recall

    Recall Number
    Z-0513-2012
    Event Number
    60643
    Firm
    Siemens Healthcare Diagnostics, Inc.
    FEI Number
    2517506
    Product Code
    JIT
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    November 17, 2011
    Posted
    January 11, 2012
    Terminated
    August 26, 2014
    Address
    500 GBC Drive PO BOX 6101, Mailstop 514, Newark, DE, 19714-6101

    Description

    Siemens Healthcare Diagnostics, Dimension Vista(R) Cardiac Troponin I Calibrator (KC678) lot 1DD085, in vitro diagnostic

    Reason

    Siemens Healthcare Diagnostics has confirmed positive bias on QC and Patients.

    Action

    Siemens healthcare Diagnostics initiated their recall of lot 1DD085 on November 17, 2011 by sending an Urgent Field Safety Notice letter to all affected customers. Customers were requested to immediately discontinue use and discard any remaining inventory of the CTNI CAL lot 1DD085.

    Distribution

    Worldwide distribution, including USA, Austria, Belgium, Canada, Denmark, Finland, France, Germany, Italy, Japan, Netherlands, New Zealand, Portugal, Puerto Rico, Slovenia, South Korea, Spain and Switzerland.

    Quantity

    2281 cartons