| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00091-1 |
| Product Name/Description |
Cobas EGFR MutationTest Kit
(An in vitro diagnostic medical device (IVD))
Catalogue Number: 06471463190
Lot Number: T08661
ARTG number: 194319 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
6/02/2015 |
| Responsible Entity |
|
| Reason/Issue |
The cobas EGFR MutationTest, Lot T08661 is generating false positive results for Exon 20 insertion mutations (i.e., false mutation detected results). This mutation is typically only observed in 1-4% of the population depending on the geographic region. The issue is currently under investigation by Roche. No other Lots or pack sizes of this product are affected by this recall. |
| Recall Action |
Recall |
| Recall Action Instructions |
Roche Diagnostics Australia is requesting the customers to review their stocks, discontinue use and discard all remaining units of the above lot number. Roche Diagnostics Australia is providing replacement kits to the customers. This action has been closed-out on 15/08/2016. |
| Contact Information |
02 9860 2222 - Roche Diagnostics Australia Pty Ltd |