Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 22934 |
| Brand Name: | Dimension clinical chemistry system and Dimension Vista System |
| Model: | Gentamicin (GENT) Flex reagent cartridge |
| Affected: | |
| 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: | The manufacturer has confirmed Dimension Gentamicin (GENT) lot BB8159 may exhibit inaccuracy for Quality Control (QC) and patient samples at the low end of the Analytical Measurement Range. Maximum negative bias of 100% and 48% were observed for patient samples at 0.9 mg/L [1.94 µmol/L] and 1.9 mg/L [4.1 µmol/L], respectively. Patient samples at 2.6 mg/L [5.62 µmol/L] did not show a bias. The bias is due to the calibration curve not showing separation between the Level 1 and Level 2 calibrators. |
| Recall action type: | Recall |
| Recall action: | Product to be destroyed |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 7/5/2018 |
