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U.S. Department of Health and Human Services

Class 3 Device Recall Siemens Dimension Vista(R) Homocysteine Flex(R) Reagent Cartridge

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  Class 3 Device Recall Siemens Dimension Vista(R) Homocysteine Flex(R) Reagent Cartridge see related information
Date Initiated by Firm August 03, 2012
Date Posted November 06, 2012
Recall Status1 Terminated 3 on January 15, 2014
Recall Number Z-0253-2013
Recall Event ID 62833
510(K)Number K063206  
Product Classification Urinary homocystine (nonquantitative) test system - Product Code LPS
Product Siemens Dimension Vista(R) Homocysteine Flex(R) Reagent Cartridge

This is an in vitro diagnostic test for the quantitative measurement of total homocysteine (HCYS) in human serum, heparinized plasma, and EDTA plasma on the Dimension Vista(R) System. Measurements of homocysteine aid in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria.

Code Information Lot numbers 12062MA, exp 12/01/2012; and 12066MA, exp 12/05/2012
Recalling Firm/
Manufacturer		 Siemens Healthcare Diagnostics, Inc.
500 Gbc Dr Ms 514
PO BOX 6101
Newark DE 19702-2466
For Additional Information Contact
800-441-9250
Manufacturer Reason
for Recall		 Cartridges are leaking. The leaking is observed when opening the wrapper that holds the reagent cartridge.
FDA Determined
Cause 2		 Packaging
Action Siemens sent a Urgent Field Safety Notice letter dated July 20, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. At this time Siemens Healthcare Diagnostics is conducting a voluntary recall for Dimension Vista¿ HCYS Flex¿ reagent cartridge lots 12062MA and 12066MA. Please immediately discontinue use and discard any remaining inventory of Dimension Vista¿ HCYS (K7044) lots 12062MA and 12066MA. Please complete the attached form and fax it to (302)631-8467 to indicate that you have received this information. We ask that you forward this notification to anyone to whom you may have distributed this lot. Contact your Siemens Customer Service Center to report your no-charge replacement needs at 888-588-3916. If you have technical questions or concerns, please contact the Siemens Technical Solutions Center at 800-441-9250 for further assistance. We apologize for the inconvenience that this situation has caused. Thank you for your patience and continued support.
Quantity in Commerce 583 cartons
Distribution USA (nationwide) including the states of AL, CA, CO, CT, DC, DE, FL, IA, IL, IN, LA, MA, MD, MI, MO, NC, NH, NJ, NM, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA 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.
510(K) Database 510(K)s with Product Code = LPS and Original Applicant = DADE BEHRING, INC.
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