Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 20178 |
| Brand Name: | Dimension Vista System Enyme 2 Calibrator |
| Model: | KC321 |
| Affected: | 4MD048, 5DD026, 5ED071, 5GD004, 5JD58, 5LD061 |
| Software version: | |
| Recalling Organisation: | Siemens Healthcare (NZ) Ltd 55 Hugo Johnston Drive Penrose Auckland |
| Contact Information: | 0800 310 300 |
| Manufacturer: | Siemens Healthcare Diagnostics Inc |
| Issue: | There have been complaints received of positive shift of patient and QC results when the ALTI assay is calibrated with the Dimension Vista Enzyme 2 Calibrator (certain lots). Confirmed that patients, quality control, and proficiency testing material all demonstrate a similar shift of up to 10% in comparison to results obtained using earlier calibrator lots. |
| Recall action type: | Correction |
| Recall action: | Manufacturer to issue advice regarding use |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 20/5/2016 |
