Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 13572 |
| Brand Name: | Siemens Dimension Vista IRON Flex reagent cartridge |
| Model: | Catalogue: K3085 / Siemens Material Number (SMN): 10445135 |
| 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 Diagnostics Inc |
| Issue: | The manufacturer has confirmed the potential for falsely elevated results with IRON Flex® reagent cartridges when tests are processed from a well set contaminated with iron from environmental sources. All lots of IRON Flex® reagent cartridges have the potential for this issue. The estimated rate is approximately 1 out of 2,500 wells. |
| Recall action type: | Correction |
| Recall action: | Software to be upgraded |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 1/10/2012 |
