| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2018-RN-00501-1 |
| Product Name/Description |
Conveyor unit (CV-50) of Sysmex XN-9000 automated haematology analysers. An in vitro diagnostic medical device (IVD)
Material Number: 06510027001
ARTG Number: 173886 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
24/05/2018 |
| Responsible Entity |
|
| Reason/Issue |
Roche have been notified by the manufacturer, Sysmex Corporation, of a potential failure of power up due to a short circuit of the PCB of CV-50 power supply unit in the event a leakage occurs from the instrument or operator error. Sysmex have identified that in rare cases, some fluid (approx 50mL) may leak from the XN-10 / XN-20 automated haematology analysers into the conveyor unit itself, resulting in short circuit of the power supply and subsequent malfunction of the conveyor.
If this issue occurs, the system will stop and patient samples will require processing by manual measurement.
Sysmex has received one complaint worldwide for this issue; none from Australian customers to date. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Roche is advising they will be in contact with customers to arrange for a technician to ensure the gaps on the outer covers of the CV-50 will be sealed with waterproof materials. This will prevent fluid from entering the power supply board.
This action has been closed out on 13/08/2019 |
| Contact Information |
02 9860 2357 - Roche Diagnostics |