Class 2 Device Recall STA Liatest

• Date Initiated by Firm: March 13, 2007
• Date Posted: July 03, 2007
• Recall Status: Terminated 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/ Manufacturer: Diagnostica Stago, Inc.; 5 Century Dr; Parsippany NJ 07054-4607
• For Additional Information Contact: Karen Wrona; 973-631-1200
• 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: Other
• 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.