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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 Recall
Dimension Vista System BUN Flex Reagent Cartridge
see related information
Date Posted March 08, 2010
Recall Status1 Terminated on November 30, 2010
Recall Number Z-1017-2010
Recall Event ID 52958
Premarket Notification
510(K) Number
K051087 
Product Classification Analyzer, Chemistry (Photometric, Discrete), For Clinical Use - 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, Delaware 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
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = JJE and Original Applicant = DADE BEHRING, INC.
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