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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 Recall
DIMENSION VISTA CHEMISTRY 3 CALIBRATOR, MODEL KC130
see related information
Date Posted May 04, 2010
Recall Status1 Terminated on June 22, 2010
Recall Number Z-1535-2010
Recall Event ID 53836
Premarket Notification
510(K) Number
K062334 
Product Classification Calibrator, Multi-Analyte Mixture - Product Code JIX
Product Dimension 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, Delaware 19714-6101
For Additional Information Contact Technical Solutions Center
800-441-9250
Manufacturer Reason
for Recall
patient results are depressed
FDA Determined
Cause 2
OTHER/UNDETERMINED: Pending
Action An "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 Commerce 1753 cartons
Distribution Worldwide distribution: USA and Australia, Canada, Japan, New Zealand, South Korea, and Switzerland.
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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