Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 16460 |
| Brand Name: | Siemens Immulite Androstenedione |
| Model: | Catalogue Numbers: LKA01 and L2KA02 |
| Affected: | 409 and above; 314 and above (respectively) |
| 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: | Siemens Healthcare Diagnostics has confirmed over-recovery of samples with concentrations greater than 5.5 ng/mL (19.2 nmol/L) with the IMMULITE/IMMULITE 1000 and IMMULITE 2000/IMMULITE 2000 XPi Androstenedione assays (LKAO1, L2KAO2). Siemens has determined that these lots are linear up to a concentration of 5.5 ng/mL (19.2 nmol/L), instead of 10 ng/mL (34.9 nmol/L) as stated in the Instructions for Use (IFU). Quality Control materials at concentrations between 5.5 ng/mL (19.2 nmol/L) and 10 ng/mL (34.9 nmol/L) will detect this issue. This is a follow up to the above where Siemens is now providing supplementary information regarding the dilution of Androstenedione samples >5.5ng/ml (19.2 nmol/L) as an alternative to verifying samples with an alternate method. |
| Recall action type: | Correction |
| Recall action: | Manufacturer to issue advice regarding use |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 27/3/2014 |
