| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00157-1 |
| Product Name/Description |
ONLINE DAT Cannabinoids II / 100 tests / 200 tests
Lot numbers: 698113, 604195, 604194, 696131, 698110 & 696133
ARTG number: 174911 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
6/03/2015 |
| Responsible Entity |
|
| Reason/Issue |
Internal investigations by Roche Diagnostics verified that the within run precision (CV) for the positive/negative control with different reagent lots is approximately 10%. The specification is lower than 8%. Patient sample results which are very close to the cutoff might recover below the cutoff. The affected reagent lots expire in May 2015.
Newer lots are not affected by the precision issue and can be used as a replacement. |
| Recall Action |
Recall |
| Recall Action Instructions |
Roche is requesting their customers to discard any remaining stock of THC II from reagent lots 69811301 and 60419501. This action has been closed-out on 02/03/2016. |
| Contact Information |
1800 645 619 - Roche National Support Centre |