| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2012-RN-01289-1 |
| Product Name/Description |
Dimension Clinical Chemistry System, Total Iron Binding Capacity. An in vitro diagnostic medical device (IVD)
Test Code: IBCT
Catalogue Number: DF84
Siemens Material Number: 10444944
ARTG number: 181687
An in vitro diagnostic medical device (IVD) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
20/12/2012 |
| Responsible Entity |
|
| Reason/Issue |
Through monitoring of method performance Siemens Healthcare Diagnostics has determined the analytical sensitivity claim of 6 ug/dL (1.1 umol/L) in the Instructions for Use (IFU) is no longer valid. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Siemens is provideding work around instructions for users to implement. |
| Contact Information |
1800 310 300 - Siemens Technical Support Centre |