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U.S. Department of Health and Human Services

Class 2 Device Recall Dimension Vista Homocysteine Flex Reagent Cartridge (HCYS)

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  Class 2 Device Recall Dimension Vista Homocysteine Flex Reagent Cartridge (HCYS) see related information
Date Initiated by Firm May 17, 2016
Create Date July 19, 2016
Recall Status1 Terminated 3 on February 07, 2018
Recall Number Z-2241-2016
Recall Event ID 74468
510(K)Number K063206  
Product Classification Urinary Homocystine (Nonquantitative) Test System - Product Code LPS
Product Dimension Vista¿ Homocysteine Flex Reagent Cartridge (HCYS), Device Listing No.: D017878 is an in vitro diagnostic test for the quantitative measurement of total homocysteine in human serum, heparinized plasma and EDTA plasma on the Dimension Vista System.
Code Information Lot Number 15243MA Mfg Date: 08/31/2015 Exp Date: 05/31/2016 Lot Number 15243MB Mfg Datge: 08/31/2015 Exp Date: 05/31/2016 
Recalling Firm/
CSL Behring GmbH
Emil-von-Behring-Str. 76
Marburg Germany
For Additional Information Contact Richard Andersen
Manufacturer Reason
for Recall
Reagent lots # 15243MA and 15243MB shows a reduced stability once opened that does not meet the Instructions For Use claim of seven (7) days. A maximum bias of -37% was observed.
FDA Determined
Cause 2
Under Investigation by firm
Action Siemens mailed an Urgent Medical Device Recall to all customers who received the affected lots notifying them of the following: 1) Discontinue use and discard any remaining inventory of the affected lots, and 2) Indicate their replacement product needs within 30 days.
Quantity in Commerce 898 units
Distribution Distributed to: AL, AR, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, LA, MA, MD, MI, MO, MS, MT, NC, NE, NH, NJ, NV, NY, OH, OR, PA, RI, SC, TN, TX, UT, VA, WI, WV
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.