Class 3 Device Recall BC Thrombin OENA11

• Date Initiated by Firm: July 21, 2004
• Date Posted: October 05, 2004
• Recall Status: Terminated on December 15, 2004
• Recall Number: Z-0007-05
• Recall Event ID: 29987
• 510(K)Number: K970645
• Product Classification: Test, Thrombin Time - Product Code GJA
• Product: BC Thrombin Reagent . Thrombin Time Test
• Code Information: Lot 540624, Lot 540625, and Lot 540626
• Recalling Firm/ Manufacturer: Dade Behring , Inc.; Rte 896, Glasgow Business Community; Newark DE 19702
• For Additional Information Contact: Donna A. Wolf; 302-631-0384
• Manufacturer Reason for Recall: The product does not demonstrate the expected prolonged thrombin times for specimens obtained from patients recieving heparin
• FDA Determined Cause: Other
• Action: The recalling firm issued a recall letter dated 7/21/04 to their accounts informing them of the problem and the need to discard the product.
• Quantity in Commerce: 3942 kits
• Distribution: The products were shipped to medical facilities in CT, FL, IA, IL, NJ, PA, and WI. The products were also shipped to Austria, Bosnia, Croatia, Hungry, Germany, Poland, Spain, RussiaFrance, Italy, Australia, Brazil, Canada, Saudi Arabia, El Salvador, and Turkey.
• 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 = GJA