Type of Product |
Medical Device |
TGA Recall Reference |
RC-2012-RN-00790-3 |
Product Name/Description |
Cobas 4800 BRAF V600 Mutation Test (acquired genetic alteration IVD). An in vitro diagnostic medical device (IVD)
Material Number: 05985595190
Lot Number: R03607
ARTG Number: 192394 |
Recall Action Level |
Hospital |
Recall Action Classification |
Class III |
Recall Action Commencement Date |
6/08/2012 |
Responsible Entity |
|
Reason/Issue |
The test kit was assembled containing two components, the WT Control and the MU Control, that were released for non-commercial internal use only. |
Recall Action |
Recall |
Recall Action Instructions |
Discontinue the use of affected product and dispose them appropriately. There is no requirement to re-test samples tested with the affected product. Roche will be supplying replacement stock when available. |
Contact Information |
02 9860 2329 - Roche Diagnostics Australia |