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U.S. Department of Health and Human Services

Class 2 Device Recall DIMENSION VISTA CHEMISTRY 3 CALIBRATOR, MODEL KC130

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 Class 2 Device Recall DIMENSION VISTA CHEMISTRY 3 CALIBRATOR, MODEL KC130see related information
Date Initiated by FirmOctober 23, 2009
Date PostedMay 04, 2010
Recall Status1 Terminated 3 on June 22, 2010
Recall NumberZ-1535-2010
Recall Event ID 53836
510(K)NumberK062334 
Product Classification Calibrator, multi-analyte mixture - Product Code JIX
ProductDimension Vista CHEM 3 calibrator is an in vitro diagnostic product for the calibration of ammonia (AMON), Cardon Dioxide (CO2) and Ethyl Alcohol (ETOH) on the Dimension Vista System
Code Information Catalog number KC130. Lot number 9ED058 exp 5/1/10
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		patient results are depressed
FDA Determined
Cause 2		Other
ActionAn "Urgent Field Safety Notice" dated October 2009 was issued by Siemens to all customers. The notice described the product, problem and actions to be taken by the customers. The customers were instructed to recalibrate the AMON method (AMON Flex reagent cartridge, K3019) with Vista Chem 3 Claibrator lot 9ED058 using the revised bottle values provided in the notice and to please consult with their laboratory director regarding re-evaluation of previous results. The customers should forward this notification to anyone to whom they may have distributed this product. If you have any technical questions regarding this information, please contact Siemens Technical Solutions Center at 1-800-441-9250.
Quantity in Commerce1753 cartons
DistributionWorldwide distribution: USA and Australia, Canada, Japan, New Zealand, South Korea, and Switzerland.
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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