Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 25775 |
| Brand Name: | Idylla EGFR Mutation Test |
| Model: | The Instructions for Use has been updated |
| Affected: | |
| Software version: | |
| Recalling Organisation: | Abacus dx New Zealand Unit B, 30 Vestey Drive Mt Wellington Auckland 1060 |
| Contact Information: | 0800222170 |
| Manufacturer: | Biocartis NV |
| Issue: | The Instructions for Use has been updated. The following limitations (Section 11; page 26) have been added/updated: 1. The Idylla™ EGFR Mutation Test is not to be used for diagnosis of NSCLC. The Idylla™ EGFR Mutation Test is to be used for patients at diagnosis and is not intended for use in a monitoring or progression setting. 2. No mutation detected" result does not rule out the presence of a mutation that may be present, but the presence is below the detection limits of the Test. In cases of sub-optimal quality and quantity [see Table 6 and Table 7 of the instructions for Use] there is a possibility that mutations close to the LOD may be missed. |
| Recall action type: | Correction |
| Recall action: | Instructions for use to be updated |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 4/3/2020 |
