| Class 2 Device Recall BCS System |  |
Date Initiated by Firm | January 14, 2016 |
Date Posted | February 19, 2016 |
Recall Status1 |
Terminated 3 on March 16, 2017 |
Recall Number | Z-0824-2016 |
Recall Event ID |
73099 |
510(K)Number | K013114 |
Product Classification |
System, multipurpose for in vitro coagulation studies - Product Code JPA
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Product | BCS Automated Blood Coagulation Analyzer System, Multipurpose system for in vitro coagulation studies, Catalog Numbers: 10454728 (BCS RECONDITIONED), 10454729 (BCS RECONDITIONED), 10454742 (BEHRING COAGULATION SYSTEM), 10459303 (BCS RECONDITIONED), 10460659 (BCS INSTRUMENT), 10461881 (BCS INSTRUMENT), IVD --- Device Listing D018966 |
Code Information |
All serial numbers |
Recalling Firm/ Manufacturer |
Siemens Healthcare Diagnostics, Inc. 511 Benedict Ave Tarrytown NY 10591-5005
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For Additional Information Contact | Customer Care Center Technical Solutions 312-275-7795 |
Manufacturer Reason for Recall | False short clotting times for PT on BCS and BCS XP with Dade Innovin can occur. This has also an effect for false low PT INR values. These false short clotting times were observed only with turbid, hemolytic and/or icteric samples from intensive care patients. The corresponding reaction curves of these samples showed a pre-peak, which can lead to falsely short clotting time. The result was not flagged by the existing check algorithms. |
FDA Determined Cause 2 | Software design |
Action | Urgent Medical Device Correction Letter (dated 1/12/2016) was sent to US consignees via FedEx on 1/14/2016 and to foreign consignees (distribution is determined at country level). The letter re-emphasizes the importance of checking the interference levels given in the respective Application Sheets of the BCS and BCS XP systems. For questions, please contact your Siemens Customer Care Center or your local Siemens technical support representative. |
Quantity in Commerce | 1680 units total |
Distribution | Worldwide Distribution-US (nationwide) and the countries of
Argentina, Australia, Austria, Bahrain, Belarus, Belgium, Bosnia Herzegovina, Brazil, Canada, Chile, China, Croatia, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Guadeloupe, Hungary, Italy, Kuwait, Latvia, Lebanon, Libya, Macedonia, Mexico, Montenegro, Netherlands, Peru, Poland, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Turkey, United Arab Emirates, and Uruguay. |
Total Product Life Cycle | TPLC Device Report |
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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.
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510(K) Database | 510(K)s with Product Code = JPA
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