Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 17750 |
| Brand Name: | Siemens Immulite 2000 and Immulite 2000xPi Androstenedione kit |
| Model: | 10381188 |
| Affected: | Lot No: 314-323 |
| 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: | During efforts to restore performance of the Androstenedione assay, manufacturer observed over-recovery in the Immulite 2000/ Immulite 2000xPi Androstenedione for samples across the assays' reportable range of 0.3 - 10 ng/ml (1.1 - 35 nmol/L). Manufacturer confirmed the issue noted in December 2013 (Medsafe ref#15975) is not limited to samples >5.5ng/ml (>19.2 nmol/L) |
| Recall action type: | Correction |
| Recall action: | Manufacturer to issue advice regarding use |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 21/11/2014 |
