| TGA Action ID |
RC-2025-RN-01050-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
UniCel DxI 600 and 800 Analysers. An in vitro diagnostic medical device (IVD).
UniCel DxI 600
Part Numbers: A71460, A30260
UDI: 15099590369224, 15099590341602
UniCel DxI 800
Part Numbers: 973100, A71456
UDI: 15099590265373, 16954701000412, 15099590369194 |
| ARTG Number |
177999 |
| Unique Device Identifier (UDI) |
15099590369224- for A71460, 15099590341602- for A30260, 15099590265373- for 973100, 16954701000412- for 973100, 15099590369194- for A71456 |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
Beckman Coulter has determined that some UniCel DxI 600 and UniCel DxI 800 Access Immunoassay Analysers may unexpectedly transition from the Running mode to the Paused or Not Ready modes because the following errors occur more frequently than expected:
- Air or excessive restriction has compromised wash buffer delivery, tests cannot run.
- Process monitoring acquisition limit exceeded.
- Process monitor general failure.
- Wash carousel did not move: Timing problem.
When these errors occur, the system may cancel tests that are currently in progress and test result processing may be delayed if there is not enough sample volume to repeat a cancelled test. This problem does not cause erroneous test results. |
| Instructions for Customers/Users |
Customers are to:
- Perform the error recovery steps listed in the Event Log troubleshooting to resume normal operation.
- Repeat the testing for any cancelled tests.
Contact Customer Beckman Coulter Technical Support if repeated recovery attempts for an error listed above fail.
This action has been closed out on 10/06/2026. |
| Action Commencement Date |
15/12/2025 |
| Responsible Entity |
|
| Contact Information |
1800 060 878 - Beckman Coulter |