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U.S. Department of Health and Human Services

Class 2 Device Recall Dimension Vista Cyclosporine Flex reagent cartridge

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  Class 2 Device Recall Dimension Vista Cyclosporine Flex reagent cartridge see related information
Date Initiated by Firm December 05, 2013
Date Posted January 23, 2014
Recall Status1 Terminated 3 on August 27, 2014
Recall Number Z-0818-2014
Recall Event ID 67057
510(K)Number K062236  
Product Classification Cyclosporine - Product Code MKW
Product Dimension Vista Cyclosporine Flex reagent cartridge

an in vitro diagnostic test for the quantitative measurement of cyclosporine A (CSA) in human whole blood on the Dimension Vista System. Measurements are used as an aid in the management of heart, liver, and kidney transplant patients.
Code Information lots 12300BB, exp. 10-26-2013; 12318BB, exp. 11-13-2013; and 13011BB, exp. 1-11-2014.
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		 Complaints were received regarding variability in recovery of QC and patient results with certain lots of the Dimension Vista CSA Flex reagent cartridges.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Siegmens sent an Urgent Medical Device Recall lletter dated December 2013 to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to discontinue use and discard any remaining inventory of the affected product. Customers were also instructed to complete the attached form and fax it to 302-631-8467. Customers were asked to retain the letter with their laboratory records, and forward the letter to any who have received the affected product. Customers with questions were instructed to contact Siemens Customer Care Center - Technical Solutions or their local Siemens technical support representative. For questions regarding this recall call 800-441-9250.
Quantity in Commerce 1586
Distribution Worldwide Distribution - USA (nationwide) and Canada.
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.
510(K) Database 510(K)s with Product Code = MKW and Original Applicant = DADE BEHRING, INC.
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