Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 13811 |
| Brand Name: | Siemens Immulite 2000/ Immulite 2000 xPi IGF-1 |
| Model: | Catalog - L2KGF2 |
| Affected: | Lot - 441-492 |
| Software version: | |
| Recalling Organisation: | Siemens Healthcare (NZ) Ltd Millennium Centre, Part Level 2, Building A 600 Great South Road Ellerslie AUCKLAND 1051 |
| Contact Information: | 0800 310 300 |
| Manufacturer: | Siemens Healthcare Diagnostics Products Limited |
| Brand Name: | Siemens Immulite/ Immulite 1000 IGF-1 |
| Model: | Catalog - LKGF1 |
| Affected: | Lot - 315-334 |
| Software version: | |
| Recalling Organisation: | Siemens Healthcare (NZ) Ltd Millennium Centre, Part Level 2, Building A 600 Great South Road Ellerslie AUCKLAND 1051 |
| Contact Information: | 0800 310 300 |
| Manufacturer: | Siemens Healthcare Diagnostics Products Limited |
| Issue: | The manufacturer has confirmed a positive shift in patient medians of approximately 20% with the IGF-1 assay. Siemens has determined that an initial positive shift of approximately 15% occcurred with Immuliate 2000/ Immulite 2000 XPi and an additiional positive shift of approximately 5% was observed with Immulite 2000/ Immulite 2000 xPi leading to the total positive shift of approximately 20%. Two potential health risks: 1. could mask uncontrolled acromegaly and thus affect patient treatment. 2. could lead to an under estimation of hGH deficiency in children with borderline hGH deficiency and potentially result in missed or delayed opportunity to treat with hGH supplement. |
| Recall action type: | Correction |
| Recall action: | Manufacturer to issue advice regarding use |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 19/11/2012 |
