Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 14642 |
| Brand Name: | Roche CoaguChek XS, CoaguChek XS Plus, and CoaguChek XS Pro Test Strips |
| Model: | Models: 04625412019, 04800842190, 05530199190, 04625374190, 04625358019, 04625315019 |
| Affected: | All serial numbers |
| Software version: | |
| Recalling Organisation: | Roche Diagnostics (NZ) Ltd 15 Rakino Way Mt Wellington AUCKLAND 1644 |
| Contact Information: | 0800 363 622 |
| Manufacturer: | |
| Issue: | In rare cases an "ERROR 6" may also be displayed by individuals who are under treatment with warfarin in combination with antibiotics and/or chemotherapeutics. In such patients INR values could be extremely high (>10 INR). If "ERROR 6" does occur we recommend repeating the test and if this continues to contact the sponsor without delay. |
| Recall action type: | Correction |
| Recall action: | Instructions for use to be updated |
| Level of recall: | Public Recall |
| Date Commenced: | 15/5/2013 |
