BEUDAMED
    FDA Recall Terminated

    Dimension(R) TACR Flex(R) reagent cartridge (DF107) The TACR method is an in vitro diagnostic test intended to quantitatively measure Tacrolimus in human whole blood on the Dimension(R) clinical chemistry system. Measurements of Tacrolimus are used as an aid in the management of Tacrolimus therapy in kidney and liver transplant patients

    Recall: Z-0517-2014 · Initiated April 25, 2013

    Recall

    Recall Number
    Z-0517-2014
    Event Number
    65051
    Firm
    Siemens Healthcare Diagnostics, Inc.
    FEI Number
    2517506
    Product Code
    MLM
    Status
    Terminated
    Root Cause
    Component design/selection
    Initiated
    April 25, 2013
    Posted
    December 16, 2013
    Terminated
    November 12, 2014
    Address
    500 Gbc Dr PO BOX 6101, Ms 514, Newark, DE, 19702-2466

    Description

    Dimension(R) TACR Flex(R) reagent cartridge (DF107) The TACR method is an in vitro diagnostic test intended to quantitatively measure Tacrolimus in human whole blood on the Dimension(R) clinical chemistry system. Measurements of Tacrolimus are used as an aid in the management of Tacrolimus therapy in kidney and liver transplant patients

    Reason

    Siemens has confirmed that the TACR method may demonstrate reduced on-board stability which may result in imprecise and inaccurate QC and patient results.

    Action

    Siemens sent an Urgent Medical Device Correction letter dated April 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. A recall notification letter was sent to consignees in April 2013. Customers using the affected product should load Flex reagent cartridges on board immediately prior to use and remove the Flex after 8 hours. Do not load more Flexes than the lab will use in 8 hours and do not pre-hydrate TACR Flexes. Customers were asked to complete the attached Effectiveness Check form and fax it to the Siemens Technical Solutions Center at 302-631-8467. Customers were asked to forward the communication to anyone to whom may have distributed the product. Customers with questions were instructed to contact the Siemens Technical Solutions Center or their local Siemens technial support representative. For questions regarding this recall call 800-441-9250.

    Distribution

    Nationwide Distribution including AK, AL, AR, AZ, CA, DC, FL, GA, IA, IL, LA, MD, MI, MO, MS, NC, NH, NJ, NM, OH, OR, PA, PR, SC, SD, TN, TX, UT, VA, WA, and WI.

    Quantity

    13,751