Class 2 Device Recall BCS(R) Behring Coagulation System

• Date Initiated by Firm: December 01, 2010
• Date Posted: June 26, 2012
• Recall Status: Terminated 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: 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