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U.S. Department of Health and Human Services

Class 2 Device Recall Dimension(R) TACR Flex(R) reagent cartridge (DF107)

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  Class 2 Device Recall Dimension(R) TACR Flex(R) reagent cartridge (DF107) see related information
Date Initiated by Firm April 25, 2013
Date Posted December 16, 2013
Recall Status1 Terminated 3 on November 12, 2014
Recall Number Z-0517-2014
Recall Event ID 65051
Product Classification Enzyme immunoassay, tracrolimus - Product Code MLM
Product 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
Code Information Siemens Material Number 10444938, lot numbers GB3099, GA3120, DB3141, GB3162, GB3176, FA3197, FA3267 and FB3267.
Recalling Firm/
Manufacturer		 Siemens Healthcare Diagnostics, Inc.
500 Gbc Dr Ms 514
PO BOX 6101
Newark DE 19702-2466
For Additional Information Contact Customer Support
800-441-9250
Manufacturer Reason
for Recall		 Siemens has confirmed that the TACR method may demonstrate reduced on-board stability which may result in imprecise and inaccurate QC and patient results.
FDA Determined
Cause 2		 Component design/selection
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.
Quantity in Commerce 13,751
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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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