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U.S. Department of Health and Human Services

Class 2 Device Recall Dimension Vista System BUN Flex Reagent Cartridge

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  Class 2 Device Recall Dimension Vista System BUN Flex Reagent Cartridge see related information
Date Initiated by Firm June 16, 2009
Date Posted March 08, 2010
Recall Status1 Terminated 3 on November 30, 2010
Recall Number Z-1017-2010
Recall Event ID 52958
510(K)Number K051087  
Product Classification in vitro diagnostic - Product Code JJE
Product Dimension Vista System BUN Flex Reagent Cartridge, Catalog number K1021, in vitro diagnostic.
Code Information Lot number 09061AA exp 2010-03-02
Recalling Firm/
Manufacturer		 Siemens Healthcare Diagnostics, Inc.
500 GBC Drive, Mailstop 514
PO BOX 6101
Newark DE 19714-6101
For Additional Information Contact Customer Service Center
800-241-0420
Manufacturer Reason
for Recall		 Incorrect result: patient sample BUN results reported may be higher or lower than actual level.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Siemens issued an Urgent Field Safety Notice dated 6/16/09 to all affected customers instructing them to discontinue use of the Dimension Vista BUN Flex reagent cartridge lot 09061AA.
Quantity in Commerce 1254 cartons
Distribution Worldwide distribution: USA, Australia, Canada, Germany, Japan, and Korea.
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 = JJE and Original Applicant = DADE BEHRING, INC.
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