| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-00025-2 |
| Product Name/Description |
BCS / BCS XP Automated Blood Coagulation Analyser with Dade Innovin .An in vitro diagnostic device (IVD)
BCS
Siemens Material Number (SMN):10454728, 10454729, 10454742, 10459303,10460659, 10461881
BCS XP
SMN: 10459330, 10462449, 10461894, 10470625
Dade Innovin
SMN: 10284500, 10445704, 10445705, 10445706, 10465673, 10465674
ARTG Numbers: 178116 & 178501 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
8/01/2016 |
| Responsible Entity |
|
| Reason/Issue |
Siemens Healthcare Diagnostics has observed that in very rare cases false short clotting times for PT on BCS and BCS XP with Dade Innovin can occur. These false short clotting times were observed with turbid, haemolytic and/or icteric samples from intensive care patients. The corresponding reaction curves of these rare samples showed a pre-peak, which can lead to falsely short clotting time. In rare cases the result was not flagged by the existing check algorithms.
There is a potential to miss a prolonged prothrombin time which could lead to a delay of intervention and a risk of a significant bleed. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Siemens is advising users check the inference levels given in the respective Application Sheets of the BCS and BCS XP systems, as such an effect can occur in turbid, haemolytic or icteric samples from intensive care patients. Siemens will provide a software upgrade which can identify irregular reaction curves in the near future. This action has been closed-out on 27/01/2017. |
| Contact Information |
1800 310 300 - Siemens Technical Support Centre |