| TGA Action ID |
RC-2025-RN-00347-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Dell OptiPlex XE4 PC – Use with Luminex IVD System. An in vitro diagnostic medical device (IVD) |
| ARTG Number |
313188 |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class III |
| Reason for the Action |
Luminex has found licensing errors on Dell OptiPlex XE4 PCs used with their systems.
The error "Invalid License" appears during installation/reinstallation of the xPONENT software.
The root cause is that the PC supplier DigitalVar, cloned PC images instead of using the Microsoft Deployment Toolkit (MDT), against Luminex’s specifications. This cloning results in duplicate digital signatures, causing license errors, especially during upgrades or modifications.
These errors only affect the xPONENT software's ability to operate the system and typically occur during maintenance, not sample runs. There is no impact on the validity of patient testing results. |
| Instructions for Customers/Users |
If customers encounter an “Invalid License” error, they need to contact Abacus dx Technical Support to resolve the problem.
Luminex has taken corrective actions to prevent this problem from reoccurring.
This action has been finalised on 30/6/2025. |
| Action Commencement Date |
26/03/2025 |
| Responsible Entity |
|
| Contact Information |
1800 222 287 - Technical Service Centre |