| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00447-1 |
| Product Name/Description |
Idylla EGFR Mutation Test. An in vitro diagnostic medical device (IVD)
Catalogue number: BTA00606
Lot number: All
UDI: 15415219111157
ARTG 262298
(Abacus dx Pty Ltd - Acquired genetic alteration IVDs) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
3/06/2024 |
| Responsible Entity |
|
| Reason/Issue |
Biocartis has identified the potential for False Positive (FP) results to be generated for the S768I target when using the Idylla EGFR Mutation Test, when tests are conducted with low sample input.
In the event of a False Positive result for the S768I target, generated by the Idylla™ EGFR Mutation Test following low sample input, it is possible that incorrect patient management decisions may be made based upon this result.
No other Biocartis Idylla™ IVD products are within the scope of this action, nor are any other mutation targets tested for by this product. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Customers are to be made aware of the updates to IFU outlined in the Customer Letter.
There is potential for S768I calls to generate false positive results with low sample input.
Exercise caution when interpreting positive S768I results in the following circumstances:
o An S768I mutation is detected, regardless of other EGFR mutations.
o The Cq value for the EGFR control is =21.9.
- If the above conditions are met, retest the patient sample(s) using a higher sample input.
- If a subsequent retest with higher sample input yields a positive result for the S768I target, contact your Abacus dx representative for further support.
- Conversely, if the subsequent retest with higher sample input gives a negative (“no mutation detected”) result for the S768I target, consider it as the final result. |
| Contact Information |
1800 222 287 - Abacus dx Pty Ltd |