BEUDAMED
    FDA Recall Terminated

    Dimension Vista CHEM 3 calibrator is an in vitro diagnostic product for the calibration of ammonia (AMON), Cardon Dioxide (CO2) and Ethyl Alcohol (ETOH) on the Dimension Vista System

    Recall: Z-1535-2010 · Initiated October 23, 2009

    Recall

    Recall Number
    Z-1535-2010
    Event Number
    53836
    Firm
    Siemens Healthcare Diagnostics, Inc.
    FEI Number
    2517506
    Product Code
    JIX
    Status
    Terminated
    Root Cause
    Other
    Initiated
    October 23, 2009
    Posted
    May 4, 2010
    Terminated
    June 22, 2010
    Address
    500 GBC Drive PO BOX 6101, Mailstop 514, Newark, DE, 19714-6101

    Description

    Dimension Vista CHEM 3 calibrator is an in vitro diagnostic product for the calibration of ammonia (AMON), Cardon Dioxide (CO2) and Ethyl Alcohol (ETOH) on the Dimension Vista System

    Reason

    patient results are depressed

    Action

    An "Urgent Field Safety Notice" dated October 2009 was issued by Siemens to all customers. The notice described the product, problem and actions to be taken by the customers. The customers were instructed to recalibrate the AMON method (AMON Flex reagent cartridge, K3019) with Vista Chem 3 Claibrator lot 9ED058 using the revised bottle values provided in the notice and to please consult with their laboratory director regarding re-evaluation of previous results. The customers should forward this notification to anyone to whom they may have distributed this product. If you have any technical questions regarding this information, please contact Siemens Technical Solutions Center at 1-800-441-9250.

    Distribution

    Worldwide distribution: USA and Australia, Canada, Japan, New Zealand, South Korea, and Switzerland.

    Quantity

    1753 cartons