| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2012-RN-00925-1 |
| Product Name/Description |
Immulite 2000, 2000 XPi EBV-EBNA IgG Assay; An in vitro diagnostic medical device (IVD)
Catalogue Number: L2KEB2
Lot Numbers: 215 and above |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
12/09/2012 |
| Responsible Entity |
|
| Reason/Issue |
The manufacturer has identified that lot to lot variability has resulted in the relative specificity not meeting the product Instructions for Use (IFU) claims. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Update to IFU claims. This action has been closed-out on 28/04/2016. |
| Contact Information |
1800 310 300 - Siemens Technical Support Centre |