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U.S. Department of Health and Human Services

Class 3 Device Recall Dimension Vista Chemistry 2 Calibrator

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  Class 3 Device Recall Dimension Vista Chemistry 2 Calibrator see related information
Date Initiated by Firm February 26, 2010
Date Posted September 09, 2010
Recall Status1 Terminated 3 on October 13, 2010
Recall Number Z-2387-2010
Recall Event ID 54743
510(K)Number K061703  
Product Classification Multi-Analyte Mixture Calibrator - Product Code JIX
Product Dimension Vista Chemistry 2 Calibrator, Catalog number KC120.

Used to calibrate Phosphate, Salicylate, and Triglycerides methods on the Dimension Vista system.
Code Information Lot number 9GM001 exp 7/2010
Recalling Firm/
Siemens Healthcare Diagnostics, Inc.
500 GBC Drive, Mailstop 514
PO BOX 6101
Newark DE 19714-6101
For Additional Information Contact Technical Solutions Center
Manufacturer Reason
for Recall
There is incorrect barcode information, which can potentially cause the Alert Message "Calibrator Insert Missing" to be displayed.
FDA Determined
Cause 2
Employee error
Action The recalling firm issued an Urgent field Safety Notice, dated February 2010, to all affected customers informing them of the problem. Customers have been told to run calibrators from cups when calibrating or request a replacement lot. The notification should be forwarded to that this product was further distributed to. Siemens Technical Solutions Center should be contacted at 800-441-9250, if they are any technical questions.
Quantity in Commerce 1310 cartons
Distribution Worldwide Distribution -- USA, Austria, Germany, Netherlands, Italy, France, Denmark, Portugal, Canada, South Korea, Malaysia, Australia, and New Zealand.
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = JIX and Original Applicant = DADE BEHRING, INC.