| TGA Action ID |
RC-2025-RN-00600-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
UniCel DxI 600/800 Access Immunoassay Analyzers. An in vitro diagnostic medical device (IVD).
UniCel DxI 800 Access Immunoassay Analyzer
DxI 800 Access Immunoassay Analyzer W/Dual Gantry
DxI 800 Access Immunoassay Analyzer W/Spot B
UniCel DxI 600 Access Immunoassay Analyzer
DxI 600 Access Immunoassay Analyzer W/Dual Gantry
DxI 600 Access Immunoassay Analyzer W/Spot B
Part numbers: 973100, A71457, A71456, A30260, A71461, A71460
Multiple serial numbers |
| ARTG Number |
177999 |
| Unique Device Identifier (UDI) |
Refer to attached UDI list |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
Beckman Coulter has determined that UniCel DxI 600/800 instruments may experience an increase in pick and place gantry events. Specific events you may encounter in the Event Log include:
• “Pick and Place hit an unexpected vessel while attempting to place vessel”
• “X Home sensor in unexpected position”
• “Vessel missing or not detected during pick and place move: Wash Pick and Place”
• “Pick and place detected an unexpected vessel: Wash Pick and Place”
• “Vessel not detected for pickup: Wash Pick and Place”
• “Vessel missing or not detected during pick and place move: Incubator Pick and Place”
• "Pick and place detected an unexpected vessel: Incubator Pick and Place”
• “Vessel not detected for pickup: Incubator Pick and Place”
• “Vessel missing or not detected during pick and place move: Sample Pick and Place”
• “Pick and place detected an unexpected vessel: Sample Pick and Place”
• “Vessel not dd for pickup: Sample Pick and Place”
The above events will coincide with a system Not Ready mode. When this occurs, the system may cancel tests currently in progress.
If sufficient sample volume is unavailable to repeat a cancelled test, there may be a delay in reporting patient results.
This problem does not cause erroneous test results. |
| Instructions for Customers/Users |
When the customer encounters any of the events described, they are to:
• Perform a system initialisation to resume normal operation.
• If repeated initialisation attempts fail, contact Customer Technical Support.
• Repeat testing for any cancelled tests.
A Beckman Coulter representative will schedule the modification installation when it is available
This action has been finalised on 14/10/2026. |
| Action Commencement Date |
7/07/2025 |
| Responsible Entity |
|
| Contact Information |
1800 060 878 - sales_aust_nz@beckman.com - Customer Administration Services |