Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 20014 |
| Brand Name: | Roche cobas EGFR Mutation Test z480 |
| Model: | 0748563190 and 07247737190 |
| Affected: | |
| Software version: | v2 CE-IVD |
| Recalling Organisation: | Roche Diagnostics (NZ) Ltd 15 Rakino Way Mt Wellington AUCKLAND 1644 |
| Contact Information: | 0800 363 622 |
| Manufacturer: | Roche Diagnostics GmbH |
| Issue: | When testing plasma specimens, several mutations inconsistently generated "No Mutation Detected" (i.e false Negative) results with the cobas EGFR Mutation test, v2 when utilising the cobas cfDNA Sample Preparation kit. Potential inhibition of plasma samples with the cobas® EGFR Mutation Test, v2 CE-IVD when used in conjunction with the cobas® cfDNA Sample Preparation Kit |
| Recall action type: | Correction |
| Recall action: | Manufacturer to issue advice regarding use |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 12/4/2016 |
