Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 20286 |
| Brand Name: | Siemens Dimension Vista System - Dimension clinical chemistry System |
| Model: | Dimension CRE2, Dimension Vista CRE2 |
| Affected: | K1033A, DF33B |
| 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: | Dimension / Dimension Vista Creatinine (CRE2) Assay exhibits a negative bias at the low end of the urine Analytical Measurement Range (AMR). The Limit of Quantitation (LoQ) claim (442 µmol/L) for urine samples is not met. This issue also affects all future lots of CRE2 until a solution is implemented. The serum/plasma CRE2 AMR is not affected by this issue. |
| Recall action type: | Correction |
| Recall action: | Manufacturer to issue advice regarding use |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 17/6/2016 |
