| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2012-RN-01022-1 |
| Product Name/Description |
IMMULITE 1000, 2000, 2000 XPi - IGF-I Control Module (Used for the detection of insulin like Growth Factor hormone). An in vitro diagnostic medical device (IVD)
Catalogue number: LGCOCM
Material number: 10385387
Lot numbers: 025L, 0025 & 0026
ARTG Number: 179720 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
10/10/2012 |
| Responsible Entity |
|
| Reason/Issue |
Siemens Healthcare Diagnostics confirmed the following:
· a negative bias against the mean values obtained with the LGCOCM control lot 0026 level 2 when used with IMMULITE®/IMMULITE® 1000 (LKGF1, SMN 10381403) kit lots 322 and above
·an increase of mean values obtained with the LGCOCM control lots 0025, 025L, and 0026 when used with IMMULITE® 2000/IMMULITE® 2000 XPi IGF-I (L2KGF2, SMN 10381448) kit lots 486 and 487. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Siemens is providing work around instructions for users to implement. |
| Contact Information |
1800 310 300 - Siemens Technical Support Centre |