| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-01252-1 |
| Product Name/Description |
Sysmex Automated Blood Coagulation Analyzer CS-2100i and 2000i. An in vitro diagnostic medical device (IVD)
Catalogue Numbers: SMN 10488583 and 10488585
Siemens Reference Number: PH 14-002
ARTG Number: 179939 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
26/11/2013 |
| Responsible Entity |
|
| Reason/Issue |
The manufacturer, has become aware about a software bug with Sysmex CS-2100i/2000i Analyzers. When the operator registers an order for micro mode and tries to modify the order, there is a risk of a mismatch between the results and sample ID numbers. Under certain circumstances, measurement results could be assigned to a wrong sample. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Siemens is providing users with work around instructions to follow. A software update will be implemented to permanently correct the issue. |
| Contact Information |
1800 310 300 - Siemens Technical Support Center |