| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00923-1 |
| Product Name/Description |
Bulk Loader Module for cobas p 471 centrifuge unit
(Automated clinical analytical systems designed to analyse biological samples for in vitro diagnostic purposes)
Part Number: 07084285001
All Lot Numbers
All Software versions
ARTG Number: 212706 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
15/09/2015 |
| Responsible Entity |
|
| Reason/Issue |
Roche has received a complaint that one sample tube was opened inadvertently in a Bulk Loader Module (BLM) during the internal system transport. The opened sample tube fell down into the funnel and the sample material was spilled, contaminating the system and other samples on their outer surface. Sample material could not be used to carry out the analysis. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
To prevent the above malfunction, a hardware modification kit has been developed and will be released by the end of September 2015, with subsequent installation by a Roche field service engineer. Until the modification kit is installed Roche is requesting that if the issue occurs end users must carryout a complete instrument clean according to the Bulk Loader Module (BLM) operator manual. This action has been closed-out on 29/08/2016. |
| Contact Information |
02 9860 2357 - Roche Diagnostics |