Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 29090 |
| Brand Name: | Enhanced Estradiol (eE2) |
| Model: | |
| Affected: | 10995561, 10995562, 10490889 & 10491445 |
| 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 (NZ) Ltd |
| Brand Name: | Atellica IM Enhanced Estradiol (eE2) 100T |
| Model: | |
| Affected: | All Lots |
| Software version: | |
| Recalling Organisation: | Siemens Healthcare (NZ) Ltd 55 Hugo Johnston Drive Penrose Auckland |
| Contact Information: | 0800 310 300 |
| Manufacturer: | Siemens Healthcare (NZ) Ltd |
| Brand Name: | Atellica IM Enhanced Estradiol (eE2) 500T |
| Model: | |
| Affected: | All Lots |
| Software version: | |
| Recalling Organisation: | Siemens Healthcare (NZ) Ltd 55 Hugo Johnston Drive Penrose Auckland |
| Contact Information: | 0800 310 300 |
| Manufacturer: | Siemens Healthcare (NZ) Ltd |
| Brand Name: | ADVIA Centaur Enhanced Estradiol (eE2) 100T |
| Model: | |
| Affected: | All Lots |
| Software version: | |
| Recalling Organisation: | Siemens Healthcare (NZ) Ltd 55 Hugo Johnston Drive Penrose Auckland |
| Contact Information: | 0800 310 300 |
| Manufacturer: | Siemens Healthcare (NZ) Ltd |
| Brand Name: | ADVIA Centaur Enhanced Estradiol (eE2) 500T |
| Model: | |
| Affected: | All lots |
| 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 (NZ) Ltd |
| Issue: | The manufacturer has confirmed customer observations of falsely elevated results when using plasma specimens across the entire Analytical Measuring Range (AMR) with the Atellica IM Enhanced Estradiol (eE2) assay. Results demonstrate that plasma specimens are not meeting claims as defined in the Instructions for Use (IFU). Limited data is available at this time as the investigation for this issue is on-going. |
| Recall action type: | Correction |
| Recall action: | Manufacturer to issue advice regarding use |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 10/3/2022 |
