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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 Device Recall Dimension Vista System CHEM 1 CAL, Catalog Number KC110see related information
Date Initiated by FirmAugust 31, 2009
Date PostedFebruary 26, 2010
Recall Status1 Terminated 3 on December 13, 2010
Recall NumberZ-0864-2010
Recall Event ID 53323
510(K)NumberK061838 
Product Classification Calibrator, multi-analyte mixture - Product Code JIX
ProductDimension 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 DE 19714-6101
For Additional Information ContactTechnical 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
ActionAn 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 Commerce1474 Cartons
DistributionNationwide and Foreign: Australia, Canada, Denmark, and Malaysia.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = JIX
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