| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00368-1 |
| Product Name/Description |
Factor IX coagulation studies on the BCS / BCS XP Automated Blood Coagulation Analyser (Actin, Actin FSL and Pathromtin SL)
Siemens Material Numbers (SMN):
BCS: 10454742, 10454729; BCS XP: 10461894, 10470625
ARTG Number: 178116
An in vitro diagnostic medical device (IVD) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
28/04/2015 |
| Responsible Entity |
|
| Reason/Issue |
Siemens has detected a situation with BCS / BCS XP analysers regarding Factor IX assay determinations for Haemophilia B patients. Internal investigations showed discrepancies for Siemens BCS / BCS XP within dilution studies. Siemens has confirmed that samples at the lower measurement range were found elevated on the BCS/BCS XP system.
Patient results in the lower measuring range may be misclassified within a higher Factor IX level. Patients that have been evaluated for hereditary factor IX deficiency disease for the first time may have to be re-evaluated.
A falsely elevated factor IX level may lead to a delay in diagnosis of a bleeding disorder related to factor IX deficiency. This may lead to additional diagnostic testing and delayed prophylactic therapy. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Siemens has provided a workaround for users along with a technical support contact number, whilst a permanent fix is being developed. Customers are advised to follow their laboratory protocol regarding the need for review of previously reported patient results.
This action has been closed-out on 01/03/2018. |
| Contact Information |
1800 310 300 - Siemens Technical Support Center |