Class 2 Device Recall

• Date Initiated by Firm: April 13, 2005
• Date Posted: August 30, 2005
• Recall Status: Terminated on October 03, 2006
• Recall Number: Z-1419-05
• Recall Event ID: 32494
• 510(K)Number: K921684
• Product Classification: Test, Time, Partial Thromboplastin - Product Code GGW
• Product: PTT-LA. Lupus anticoagulant-sensitive APTT reagent. Diagnostica Stago, 6x 2mL.. Distributed in the USA by: Diagnostica Stago, Inc., Five Century Drive, Parsippany, NJ 07054.
• Code Information: Cat. No. 00599 Lot Number 041755 exp. 06/06.
• Recalling Firm/ Manufacturer: Diagnostica Stago, Inc.; 5 Century Dr; Parsippany NJ 07054-4607
• For Additional Information Contact: James Barrow; 800-222-2624 Ext. 116
• Manufacturer Reason for Recall: Variable clotting times observed with the PTT-LA, Lupus Anticoagulant-Sensitive APTT Reagent.
• FDA Determined Cause: Other
• Action: On 4/13/2005, recall notification letters were sent to all customers and instructed them to stop using the kits and to dispose of the kits according to local regulations.
• Quantity in Commerce: 740 kits
• Distribution: The firm distributed this product to 32 clinics/laboratories/hospitals 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 = GGW