Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 18964 |
| Brand Name: | Biocartis NVIdylla™ KRAS Mutation Test |
| Model: | A0020 |
| Affected: | 2207 |
| Software version: | |
| Recalling Organisation: | Abacus ALS Limited 55b Richard Pearse Drive Airport Oaks Auckland 2022 |
| Contact Information: | 0800 222 170 |
| Manufacturer: | Biocartis NV |
| Issue: | Two false negative results were obtained during initial laboratory validation testing in a Belgian clinical laboratory. A "No mutation detected in KRAS codon 12,13,59,61,117,146'" result was reported on a reference material of Horizon, containing 5 % allelic frequency of G12A, using the Idylla™ KRAS Mutation Test, lot 2207. |
| Recall action type: | Recall |
| Recall action: | Product to be returned to supplier |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 11/8/2015 |
