Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 15350 |
| Brand Name: | Roche cobas HbA1c tests |
| Model: | Material number: 06378676190 |
| Affected: | Lot Numbers: 303022-01, 304021-01, 304022-01, 304023-01, 304024-01, 304025-01, 305021-01, 306022-01, 306023-01, 307021-01 |
| Software version: | |
| Recalling Organisation: | Roche Diagnostics (NZ) Ltd 15 Rakino Way Mt Wellington AUCKLAND 1644 |
| Contact Information: | 0800 363 622 |
| Manufacturer: | |
| Issue: | The manufacturer advises that the lots specified show imprecision for HbA1c patient results. The storage stability data shows a deviation in the range of -10% up to -30% from the target value with an error rate of up to 40%. No deviation was found with previous lots. |
| Recall action type: | Recall |
| Recall action: | Product to be destroyed |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 11/9/2013 |
