Recall Z-0824-2016 ยท JPA System, Multipurpose For In Vitro Coagulation Studies
Siemens Healthcare Diagnostics, Inc.
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
| Date | Feb 19, 2016 (initiated Jan 14, 2016) |
| Status | Terminated |
| Reason | 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. |
| Root cause | 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 | 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, Mac |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K013114 | BCS SYSTEM Dade Behring, Inc., Nov 9, 2001 |