| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00214-1 |
| Product Name/Description |
IMMULITE 2500 IGF-I (An in vitro diagnostic medical device (IVD))
Catalogue Number: L5KGF2
Siemens Material Number: 10381367
Lot Numbers: 189 - 227
ARTG Number: 179720 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
14/03/2013 |
| Responsible Entity |
|
| Reason/Issue |
Siemens confirm a negative bias in patient medians of approximately 5 to 20% using the IGF-I assay as compared to the reference range medians provided in the IGF-I Instructions for Use (IFU) with kit lots released August 2008 through July 2011. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Laboratories to implement the work-around provided by the sponsor. A review of previously reported results should be considered. |
| Contact Information |
1800 310 300 - Siemens Technical Support Centre |