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U.S. Department of Health and Human Services

Class 2 Device Recall STA Liatest

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  Class 2 Device Recall STA Liatest see related information
Date Initiated by Firm March 13, 2007
Date Posted July 03, 2007
Recall Status1 Terminated 3 on January 16, 2009
Recall Number Z-0853-2007
Recall Event ID 37746
Product Classification Von Willebrand Factor-Immuno-Turbidimetric Assay - Product Code GGP
Product STA Liatest VWF:Ag, Product Catalog Number : 0518. This is a Immuno-Turbidimetric Assay of von Willebrand Factor.
Code Information Lot -- Exp:  052783 -- April 2007; 061242 -- November 2007; 061981 -- February 2008.
Recalling Firm/
Diagnostica Stago, Inc.
5 Century Dr
Parsippany NJ 07054-4607
For Additional Information Contact Karen Wrona
Manufacturer Reason
for Recall
A dose-hook effect is observed starting from VWF:AG levels of 300%, while the package insert indicates that no dose-hook effect has been observed with VWF:Ag levels up to 800%.
FDA Determined
Cause 2
Action Customers were notified on March 13, 2007 by letter, first class mail.
Quantity in Commerce 1,098 units
Distribution Hospitals and laboratories Nationwide
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.