BEUDAMED
    FDA Recall Terminated

    Siemens Healthcare Diagnostics, Inc. Dimension(R) EXL Cardiac Troponin I Flex(R) Reagent Cartridges

    Recall: Z-0069-2012 · Initiated August 31, 2011

    Recall

    Recall Number
    Z-0069-2012
    Event Number
    59889
    Firm
    Siemens Healthcare Diagnostics, Inc.
    FEI Number
    2517506
    Product Code
    JJE
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    August 31, 2011
    Posted
    October 19, 2011
    Terminated
    January 14, 2014
    Address
    500 Gbc Dr PO BOX 6101, Ms 514, Newark, DE, 19702-2466

    Description

    Siemens Healthcare Diagnostics, Inc. Dimension(R) EXL Cardiac Troponin I Flex(R) Reagent Cartridges

    Reason

    Firm has confirmed customer complaints for low recovery of QC and patient samples.

    Action

    Siemens Healthcare Diagnostics, Inc. Urgent Field Safety Notice was sent to customers on August 31, 2011 regarding the issue. The letter instructs customers to immediately discontinue use of the affected lots and discard all remaining inventory.

    Distribution

    Worldwide distribution: USA, Puerto Rico, Guam, Austria, Canada, Croatia, France, Greece, Germany, Italy, Japan, Mexico, Portugal, Spain and Switzerland.

    Quantity

    6,072 cartons