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U.S. Department of Health and Human Services

Class 2 Device Recall Dimension Vista System CHEM 1 CAL, Catalog Number KC110

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 Class 2 Recall
Dimension Vista System CHEM 1 CAL, Catalog Number KC110
see related information
Date Posted February 26, 2010
Recall Status1 Terminated on December 13, 2010
Recall Number Z-0864-2010
Recall Event ID 53323
Premarket Notification
510(K) Number
K061838 
Product Classification Calibrator, Multi-Analyte Mixture - Product Code JIX
Product Dimension Vista System CHEM 1 CAL, Catalog Number KC110, Lot Number 9DM001 The Dimension Vista CHEM 1 CAL is an in vitro diagnostic product for the calibration of Calcium (CA), Cholesterol (CHOL), Creatinine (CREA), Glucose (GLU), Lactic Acid (LA), Magnesium (MG), Thyroxine (T4), Thyronine Uptake (TU), Blood Urea Nitrogen (BUN) and Uric Acid (URCA) methods on the Dimension Vista System
Code Information Lot Number 9DM001
Recalling Firm/
Manufacturer
Siemens Healthcare Diagnostics, Inc.
500 GBC Drive, Mailstop 514
PO BOX 6101
Newark, Delaware 19714-6101
For Additional Information Contact Technical Solutions Center
800-441-9250
Manufacturer Reason
for Recall
Siemens Healthcare Diagnostics, Inc. has confirmed high accuracy shifts with Dimension Vista URCA Flex reagent cartridge (various lots) when calibrating with some vials from CHEM 1 calibrator lot 9DM001.
FDA Determined
Cause 2
OTHER/UNDETERMINED: Pending
Action An Urgent Field Safety Notice dated August 31, 2009, was issued to all affected customers. Customers were instructed to discontinue the use of Dimension Vista System CHEM 1 Cal lot 9DM001 and discard any remaining product. If customers have any question they can contact Technical Solutions at 1-800-241-0420.
Quantity in Commerce 1474 Cartons
Distribution Nationwide and Foreign: Australia, Canada, Denmark, and Malaysia.
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 = JIX and Original Applicant = DADE BEHRING, INC.
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