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U.S. Department of Health and Human Services

Class 2 Device Recall BCS(R) Behring Coagulation System

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  Class 2 Device Recall BCS(R) Behring Coagulation System see related information
Date Initiated by Firm December 01, 2010
Date Posted June 26, 2012
Recall Status1 Terminated 3 on March 05, 2014
Recall Number Z-1867-2012
Recall Event ID 61768
510(K)Number K013114  
Product Classification System, multipurpose for in vitro coagulation studies - Product Code JPA
Product BCS(R) Behring Coagulation System, Device catalog No. OVIO03

Product Usage:
Multipurpose system for In Vitro coagulation studies
Code Information Device catalog No. OVIO03 (not lot specific)
Recalling Firm/
Manufacturer		 Siemens Healthcare Diagnostics, Inc.
500 GBC Drive, Mailstop 514
PO BOX 6101
Newark DE 19714-6101
For Additional Information Contact Robert J. King
302-631-0516
Manufacturer Reason
for Recall		 Firm has confirmed that if the Cleaner SCS vial becomes empty after processing a test for Antithrombin assay using the INNOVANCE(R) Antithrombin kit, and the test immediately following is an APTT based clotting assay several results may be shortened.
FDA Determined
Cause 2		 Device Design
Action An Urgent Field Safety Notice dated December 2010 was issued to all BCS(R) System owners. Firm conducted a voluntary field corrective action to notify BCS(R) System owners and to install a software "patch" to resolve the issue. Until the software patch was installed on the BCS(R) System, customers were instructed in the Safety Notice that "the potential issue of carryover can be avoided if the Cleaner SCS vial is kept filled and not allowrd to run empty."
Quantity in Commerce 186
Distribution Worldwide Distribution - US (nationwide) including the states of: AZ, AR, CA, CO, CT, FL, GA, ID, IL, IN, IO, KS, KY, LA, MD, MA, MI, MS, MN, MT, NE, NH, NJ, NY, NC, ND, OH, OK, OR, PA, TN, TX, UT, VA, WA, WV, and WI and the countries of: Australia, France, Canary Islands, Spain, Belgium, Germany, Switzerland, Netherlands, Italy, Guadeloupe, Ceuta, Austria, Slovenia, Croatia, Saudi Arabia, Turkey, Greece, and San Marino.
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 = JPA and Original Applicant = DADE BEHRING, INC.
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