Class 3 Device Recall STA Liatest

• Date Initiated by Firm: May 08, 2007
• Date Posted: August 09, 2007
• Recall Status: Terminated on October 13, 2010
• Recall Number: Z-1072-2007
• Recall Event ID: 37952
• 510(K)Number: K912468
• Product Classification: in vitro diagnostic - Product Code GGP
• Product: STA Liatest Free Protein S For in vitro diagnostic use. 2-8 degrees C Distributed in the USA by: Diagnostica Stago, Inc. 5 Century Drive Parsippany, NJ Phone 800-abc coag 1 - 6 x 5 ml Buffer 2 - 6 x 6 ml Latex
• Code Information: Catalog number: 0516 Lot Numbers: 061312, Exp 5/31/07; 061991, Exp 8/31/07; 062633, Exp 10/31/07; 063281, Exp 12/31/07
• Recalling Firm/ Manufacturer: Diagnostica Stago, Inc.; 5 Century Dr; Parsippany NJ 07054-4607
• For Additional Information Contact: Melissa Cole; 973-631-1200 Ext. 4416
• Manufacturer Reason for Recall: Specific lots of STA Liatest Free Protein S may result in low results in the assigned value ranges and sometimes outside the lower limit.
• FDA Determined Cause: Other
• Action: Customers were sent a Product Recall Notification on May 8, 2007 by first class mail labeled " Recall notice, Open Immediately"
• Quantity in Commerce: 365 units
• Distribution: Medical facilities 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.

• 510(K) Database: 510(K)s with Product Code = GGP