Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 20244 |
| Brand Name: | Dimension Vista System - Blood Urea Nitrogen (BUN) Flex |
| Model: | K1021 |
| Affected: | 16004AB, 16033AC, 16034AA, 16048AA, 16055AA,16055AB, 16062AA,16062AB |
| 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: | In February 2016, Siemens Healthcare Diagnostics issued field corrective action letter VC 16-01, informing customers of well-to-well accuracy shifts for specific lots of Dimension Vista BUN causing inaccurate patient and/or Quality Control results. At that time, preliminary investigation demonstrated loss of enzymatic activity of the GLDH reagent wells made from a specific mold/cavity. They have since confirmed complaints on additional Vista BUN Flex cartridge lots, suggesting an additional cause of reduced GLDH activity. |
| Recall action type: | Recall |
| Recall action: | Product to be exchanged |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 9/6/2016 |
