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U.S. Department of Health and Human Services

Class 3 Device Recall BC Thrombin OENA11

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  Class 3 Device Recall BC Thrombin OENA11 see related information
Date Initiated by Firm July 21, 2004
Date Posted October 05, 2004
Recall Status1 Terminated 3 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/
Dade Behring , Inc.
Rte 896, Glasgow Business Community
Newark DE 19702
For Additional Information Contact Donna A. Wolf
Manufacturer Reason
for Recall
The product does not demonstrate the expected prolonged thrombin times for specimens obtained from patients recieving heparin
FDA Determined
Cause 2
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 and Original Applicant = BEHRING DIAGNOSTICS, INC.