Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 17429 |
| Brand Name: | Siemens Dimension Vista Hemoglobin A1c (HbA1c) Flex Reagent Cartridge |
| Model: | Catalogue Number: K3105A |
| Affected: | Lots: 13294BA, 13308BA, 13329AA, 13350AA, 14006AA, 14041BA, 14069BB, 14083BA |
| 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: | Siemens has confirmed that certain lots of the Dimension Vista® HbA1c Flex® reagent cartridge exhibit a positive bias averaging 0.4% [4.4 mmol/mol] Hemoglobin A1c units and occasionally up to 1.0% [11 mmol/mol] HbA1c units for patient samples when compared to the National Glycohemoglobin Standardization Program (NGSP). QC samples may exhibit a similar bias |
| Recall action type: | Recall |
| Recall action: | Product to be destroyed |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 25/9/2014 |
