| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-01279-1 |
| Product Name/Description |
Rack Trays used with cobas, Modular Analytics and Urisys instruments/systems. An in vitro diagnostic medical device (IVD).
Various Rack Trays and instruments affected
Multiple Material Numbers affected
ARTG Numbers: 173887 & 212706 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
5/10/2016 |
| Responsible Entity |
|
| Reason/Issue |
Roche is updating the cleaning procedure for rack trays that are used with various cobas, Modular Analytics and Urisys instruments as a result of reports of injury caused by sharp edges on the rack trays during cleaning. Cuts may occur when fingers come in contact with rack tray edges, especially if a quick wiping movement is made along the edges of the rack tray. The updated cleaning procedure contains instructions for safe handling of the parts to avoid the risk of injury. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Roche is providing users with updated cleaning instructions for the rack trays. This information will be incorporated into future versions of the respective instrument Operator Manuals. This action has been closed-out on 17/05/2017. |
| Contact Information |
02 9860 2357 - Roche Diagnostics Australia |