BEUDAMED
    FDA Recall Terminated

    Dimension Tacrolimus Flex Reagent Cartridge, manufactured by Siemens Healthcare Diagnostics Inc., Newark, Delaware.

    Recall: Z-2407-2010 · Initiated June 15, 2010

    Recall

    Recall Number
    Z-2407-2010
    Event Number
    56145
    Firm
    Siemens Healthcare Diagnostics, Inc.
    FEI Number
    2517506
    Product Code
    MLM
    Status
    Terminated
    Root Cause
    Other
    Initiated
    June 15, 2010
    Posted
    September 13, 2010
    Terminated
    December 16, 2010
    Address
    500 GBC Drive PO BOX 6101, Mailstop 514, Newark, DE, 19714-6101

    Description

    Dimension Tacrolimus Flex Reagent Cartridge, manufactured by Siemens Healthcare Diagnostics Inc., Newark, Delaware.

    Reason

    Low patient sample recovery results in all affected lots, with possibility of inappropriate increase in tacrolimus dosage based on false low result.

    Action

    Siemens issued an "Urgent Field Safety Notice" dated June, 2010 to all affected customers. Customers were requested to immediately discontinue use and discard any remaining inventory of the TACR Flex reagent lots DC0306, CA0320, DA0334 and GA0348. The letter contains the following instructions: 1) Immediately discontinue use of the affected lots; 2) Discard all remaining inventory of the affected lots; 3) Contact Siemens Healthcare Diagnostics Technical Solutions Center for replacement product; 4) Complete and return the Field Correction Effectiveness Check by fax to 302 631-8467; 4) Siemens is recommending that the content of the letter should be discussed with the laboratory director. If unexpectedly low results are obtained on a patient sample, caution should be exercised before decisions regarding therapeutic dosage adjustments are made. As stated in the package insert, "Confirmation of unexpected or atypical results by an alternative methodology is recommended prior to any adjustments in tacrolimus dosage. Also individual tacrolimus values cannot be used as the sole indicator for making changes in the treatment regimen. Each patient should be thoroughly evaluated clinically before treatment adjustments are made." Siemens Technical Solutions Center may be contacted at 800-441-9250

    Distribution

    Worldwide Distribution to USA states of AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, IA, IL, KS, LA, MI, MO, MS, NC, NE, NH, NJ, NM, NY, OH, OR, PA, SC, SD, TN, TX, UT, VA, WA and WI, and countries of Austria, Belgium, Canary Islands, Egypt, France, Germany, Great Britain, Hungary, Italy, The Netherlands, Poland, Portugal, Romania, Saudi Arabia, Slovakia, Spain, Sweden, United Arab Emirates, Argentina, Brazil, Canada, Columbia, El Salvador, Venezuela, Australia, Hong Kong, India, Japan, Malaysia, New Zealand, South Korea, Singapore, Taiwan and China.

    Quantity

    4580 Cartons