Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 20972 |
| Brand Name: | Siemens Dimension Vista V-LYTE Intergrated Multisensor |
| Model: | |
| Affected: | SMN 10484429 |
| 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 a low bias for Dimension Vista V-LYTE Integrated Multisensor urine potassium (K) when compared to the Dimension QuikLYTE Integrated Multisensor, which is the predicate device used in the method comparison section of the V-LYTE Instructions for Use (IFU). Our testing showed a bias of -4.9% at a urine potassium concentration of 39.6 mmol/L, -19.6% at a urine potassium concentration of 32.8 mmol/L, and an average bias of -10.9% over the urine potassium concentration range of 7.5 to 133.7 mmol/L. This bias affects patient results, QC and could result in failures in accuracy-based proficiency testing program. The manufacturer is issuing this follow-up notification with enhanced instructions for updating and verifying the urine potassium method comparison coefficients. |
| Recall action type: | Correction |
| Recall action: | Software to be upgraded |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 1/2/2017 |
