Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 20609 |
| Brand Name: | Biocartis Idylla KRAS Mutation Test IVD |
| Model: | |
| Affected: | Lot 2663 |
| Software version: | |
| Recalling Organisation: | Abacus ALS 12 Mowbray Terrace East Brisbane QLD 4169 Australia |
| Contact Information: | |
| Manufacturer: | Biocartis NV |
| Issue: | A potential increased risk of false positive results of the A59E/G/T mutation by the Idylla™ KRAS Mutation Test has been identified This could result in an incorrectly reported A59E/G/T mutation. A false positive result on A59E/G/T mutation could lead to sub-optimal patient treatment. |
| Recall action type: | Correction |
| Recall action: | Instructions for use to be updated |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 5/9/2016 |
