Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 22946 |
| Brand Name: | Accu-Chek Inform II test strips |
| Model: | |
| Affected: | Lot Number: 476618 |
| Software version: | |
| Recalling Organisation: | Roche Diagnostics (NZ) Ltd 15 Rakino Way Mt Wellington AUCKLAND 1644 |
| Contact Information: | 0800 363 622 |
| Manufacturer: | Roche Diagnostics GmbH |
| Issue: | The manufacturer has identified a potential issue where specific lots for Accu-Chek Inform II test strips are not meeting product specifications. The issue has coincided with an observed higher than expected amount of Strip Errors Before Dose and an increased potential for biased results. Investigation of returned, complaint test strips identified cracking of the reagent and underlying electrode as the cause of the failures. |
| Recall action type: | Recall |
| Recall action: | Product to be destroyed |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 8/5/2018 |
