| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2012-RN-00782-3 |
| Product Name/Description |
Cobas IT 3000 Haematology Performance Suite, keyboard differential keyboard (with Cobas IT 3000 versions 2.03.08 to 2.04.00). An in vitro diagnostic medical device (IVD)
|
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
8/08/2012 |
| Responsible Entity |
|
| Reason/Issue |
There is a potential that the analyte comments may be deleted if the specific analyte is not counted in the mask. This risk is avoided in the case that the user makes comments against the “Blood Film Comments” analyte for reporting blood film comments.
The differential keyboard orders a profile that contains all of the additional blood cell types that can be manually counted. In many instances these additional cell types will not be identified in the count and will not receive a result (eg Blasts, Myelocytes, etc). The expected behaviour is that if a cell is not counted, then these analytes will be removed from the profile when the final count is accepted. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Roche is providing work around instructions until a software upgrade can be implemented to permanently fix the issue. |
| Contact Information |
1800 645 619 - Roche National Support Centre |