| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00648-1 |
| Product Name/Description |
PSA Assays for use on Immulite, Immulite 1000, Immulite 2000 and Immulite 2000 XPi analysers (an in vitro diagnostic medical device)
Multiple Lot numbers affected
Multiple Catalogue numbers affected
All kit lots released in February 2012.
ARTG Number: 180971 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
28/06/2013 |
| Responsible Entity |
|
| Reason/Issue |
Siemens Healthcare Diagnostics has confirmed an overall average positive bias of approximately 20%-23% across the assay range relative to WHO 96/670 with the IMMULITE Systems PSA assays. This positive bias is observed in patient values and the Siemens Tumor Marker controls (TMCO). |
| Recall Action |
Recall |
| Recall Action Instructions |
Siemens are advising users to discontinue use and discard any remaining kits. Replacement kits will be available in July 2013. Siemens is recommending a lookback period of two months of previous test results. For results that were recorded as abnormal, please notify the treating physician. Actions by the clinician may be to reconsider a scheduled biopsy based on the test result taking into account the other factors that made biopsy a consideration. |
| Contact Information |
1800 310 300 - Siemens Technical Support Centre |