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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 Recall
Dimension Vista Chemistry 2 Calibrator
see related information
Date Posted September 09, 2010
Recall Status1 Terminated on October 13, 2010
Recall Number Z-2387-2010
Recall Event ID 54743
Premarket Notification
510(K) Number
K061703 
Product Classification Calibrator, Multi-Analyte Mixture - 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/
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
There is incorrect barcode information, which can potentially cause the Alert Message "Calibrator Insert Missing" to be displayed.
FDA Determined
Cause 2
TRAINING: 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 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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