| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2012-RN-01028-1 |
| Product Name/Description |
IMMULITE 2000 / IMMULITE 2000 XPi ACTH Control module (Used for the detection of Adrenocorticotropic hormone). An in vitro diagnostic medical device (IVD)
Catalogue Number: LACCM
Lot Number: 0018
Siemens Material Number: 10385382 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
10/10/2012 |
| Responsible Entity |
|
| Reason/Issue |
It has been confirmed that there is a tendency for an increase in the mean values obtained with the LACCM control lot 0018 when used with IMMULITE 2000/IMMULITE 2000 XPi kit lots 240 and above. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Siemens is providing work around instructions for users to follow. |
| Contact Information |
1800 310 300 - Siemens Technical Support Centre |