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U.S. Department of Health and Human Services

Class 2 Device Recall Dimension Tacrolimus Flex Reagent Cartridge

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 Class 2 Recall
Dimension Tacrolimus Flex Reagent Cartridge
see related information
Date Posted September 13, 2010
Recall Status1 Terminated on December 16, 2010
Recall Number Z-2407-2010
Recall Event ID 56145
Premarket Notification
510(K) Number
K060502 
Product Classification Enzyme Immunoassay, Tracrolimus - Product Code MLM
Product Dimension Tacrolimus Flex Reagent Cartridge, manufactured by Siemens Healthcare Diagnostics Inc., Newark, Delaware.
Code Information Lot Numbers: DC0306 (exp 11/2/10), CA0320 (exp 11/16/10), DA0334 (exp 11/30/10), GA0348 (exp 12/14/10)
Recalling Firm/
Manufacturer
Siemens Healthcare Diagnostics, Inc.
500 GBC Drive, Mailstop 514
PO BOX 6101
Newark, Delaware 19714-6101
For Additional Information Contact Siemens Technical Solutions Center
800-441-9250
Manufacturer Reason
for Recall
Low patient sample recovery results in all affected lots, with possibility of inappropriate increase in tacrolimus dosage based on false low result.
FDA Determined
Cause 2
OTHER/UNDETERMINED: Pending
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.
Quantity in Commerce 4580 Cartons
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.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = MLM and Original Applicant = DADE BEHRING, INC.
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