Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 28339 |
| Brand Name: | cobas® EGFR Mutation Test v2 |
| Model: | |
| Affected: | false mutation detected results for exon20 insertion when using the cobas EGFR Mutation Test v2. |
| 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 received complaints from customers reporting the generation of false Mutation Detected results for the exon 20 insertion (Ex20Ins) mutation when using the cobas EGFR Mutation Test v2. |
| Recall action type: | Correction |
| Recall action: | |
| Level of recall: | |
| Date Commenced: | 14/9/2021 |
