Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 14469 |
| Brand Name: | Siemens Dimension Vista Hemoglobin A1c (HbA1c) Flex reagent cartridge |
| Model: | K3105A |
| Affected: | Lots: 12072AA, 12150AA, 12248AA, 12086AA, 12191AA, 12261AA, 12107AA, 12212AA, 12282AA, 12128AA, 12226AA, 12303AA |
| 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: | There are two issues with HbA1c: (1) Customers have been experiencing a higher frequency of “above assay range” flags on patient samples with the Vista HbA1c method. (2) Some customers have experienced a high bias on patients' samples and US CAP survey samples (2012 GH2-B) with the Vista HbA1c method. |
| Recall action type: | Recall |
| Recall action: | Product to be destroyed |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 8/4/2013 |
