BEUDAMED
    FDA Recall Terminated

    Dimension Vista(R) Systems Vista(R) Theophylline THEO Flex(R) Regent Cartridge (K4071) The THEO method is an in vitro diagnostic test for the quantitative measurement of Theophylline in human serum and plasma on the Dimension Vista(R) system.

    Recall: Z-0408-2013 · Initiated August 9, 2012

    Recall

    Recall Number
    Z-0408-2013
    Event Number
    62835
    Firm
    Siemens Healthcare Diagnostics, Inc.
    FEI Number
    2517506
    Product Code
    KLS
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    August 9, 2012
    Posted
    November 20, 2012
    Terminated
    January 8, 2014
    Address
    500 GBC Drive PO BOX 6101, Mailstop 514, Newark, DE, 19714-6101

    Description

    Dimension Vista(R) Systems Vista(R) Theophylline THEO Flex(R) Regent Cartridge (K4071) The THEO method is an in vitro diagnostic test for the quantitative measurement of Theophylline in human serum and plasma on the Dimension Vista(R) system.

    Reason

    Firm has received complaints from customers of "Abnormal Reaction" errors occurring on calibrations, QC and patient samples. The Abnormal Reaction flag is being triggered by an internal check in the method for atypical particle reagent aggregation.

    Action

    Siemens Healthcare Diagnostic sent a Urgent Field Safety notice dated July, 20. 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Please immediately discontinue use and discard any remaining inventory of Dimension Vista Theophylline Flex reagent cartridge (THEO, Catalog # K4071) lot 12135AE and/or 12171BB. Please complete the attached form and fax it to (302)631-8467 to indicate that you have received this information and to facilitate your additional no charge replacement. We ask that you forward this notification to anyone to whom you may have distributed this lot. If you have technical questions or concerns, please contact the Siemens Technical Solutions Center at 800-441-9250 for further assistance. For questions concerning the status of your no charge replacement order please contact your Siemens Customer Service Center at 888-588-3916. We apologize for the inconvenience that this situation has caused. Thank you for your patience and continued support.

    Distribution

    USA (nationwide) including the states of AL, AZ, CA, CO, DC, DE, FL, GA, IL, IN, KY, LA, MA, MD, MI, MO, MS, MT, NC, NH, NJ, NY, OH, OR, PA, SC, TN, TX, VA, VT, WA and WI.

    Quantity

    959 cartons