Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 17996 |
| Brand Name: | Roche Cobas EGFR Mutation Kit CE-IVD |
| Model: | |
| Affected: | Lot: T08661 |
| Software version: | |
| Recalling Organisation: | Roche Diagnostics (NZ) Ltd 15 Rakino Way Mt Wellington AUCKLAND 1644 |
| Contact Information: | 0800 363 622 |
| Manufacturer: | |
| Issue: | The cobas® EGFR Mutation Kit, lot T08661, is generating false positive results for Exon 20 insertion mutations. This mutation is typically only observed in 1-4% of the population, depending on the region. |
| Recall action type: | Recall |
| Recall action: | Product to be destroyed |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 23/1/2015 |
