| TGA Action ID |
RC-2025-RN-00420-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
DxI 9000 Access Immunoassay Analyzer. An in vitro diagnostic medical device (IVD).
REF: C11137
Software Version: 1.20 |
| ARTG Number |
177999 |
| Unique Device Identifier (UDI) |
15099590732103 |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
Beckman Coulter has determined that DxI 9000 Access Immunoassay Analyzers on software version 1.20 may experience an increase in reaction vessel (RV) supply homing failures during system initialisation.
These homing failures will cause the analyser to fail initialisation and will result in a red system event with the following description: “RVSupplyAssembly – MachineControlStatus (RVSupply was not homed)”.
If repeated initialisation attempts continue to fail and a service visit is required to resolve the problem, there may be a delay in reporting test results which could lead to a delay in patient treatment.
This problem does not cause erroneous patient test results. |
| Instructions for Customers/Users |
If your laboratory has experienced the red system event and it is not resolved by initialising the analyser, contact your Beckman Coulter representative and schedule a service visit.
A Beckman Coulter representative will also schedule the installation modification when it is available.
This action has been finalised on 28/7/2025. |
| Action Commencement Date |
24/04/2025 |
| Responsible Entity |
|
| Contact Information |
02 9844 6000 - Sara Panahi |