Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 18682 |
| Brand Name: | Roche cobas KRAS Mutation Kit |
| Model: | |
| Affected: | T154735, T15475, T13091, T14777, W00389 |
| Software version: | |
| Recalling Organisation: | Roche Diagnostics (NZ) Ltd 15 Rakino Way Mt Wellington AUCKLAND 1644 |
| Contact Information: | 0800 363 622 |
| Manufacturer: | |
| Issue: | Roche has identified that certain lots of the cobas KRAS Mutation Kits are generating invalid results for the Mutant Control and/or KRAS Calibrator at a much higher rate than expected during routine stability monitoring. |
| Recall action type: | Recall |
| Recall action: | Product to be destroyed |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 18/6/2015 |
