| TGA Action ID |
RC-2025-RN-00831-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
DxI 9000 Access Immunoassay Analyzer. An in vitro diagnostic medical device (IVD).
UDI: 15099590732103
Catalogue number: C11137
Software 1.22 and below |
| ARTG Number |
177999 |
| Unique Device Identifier (UDI) |
15099590732103 |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
The analyser may fail to apply a dilution factor to tests associated with a manually diluted sample when the tests are ordered through the Test Order Entry page and a unique sample ID is not used.
The problem occurs under the following conditions:
1. A sample is presented to the analyser from the sample handler or an automation system.
2. While tests associated with the sample are in progress:
· The sample is manually diluted.
· Additional tests are ordered through the Test Order Entry page, and a dilution factor is entered.
· The sample ID used for the original test requests is also used for the tests ordered with the diluted sample.
3. When tests ordered for the diluted sample are complete, the user interface correctly displays the dilution factor that was entered on the Test Order Entry page. However, the analyser does not apply the dilution factor to the result.
Automated dilutions and tests ordered using the Dilute and Rerun feature are not affected by this problem.
This problem can lead to a falsely low or falsely elevated result when not using a unique sample ID for manual dilutions. |
| Instructions for Customers/Users |
Beckman Coulter is investigating the root cause of this problem and will implement a correction with a future software release.
A Beckman Coulter service representative will contact customers to schedule the software upgrade when it is available.
In the interim:
- When ordering tests for a manually diluted sample through the Test Order Entry page, a unique sample ID is required.
- Alternatively, use the Dilute and Rerun feature or an automated dilution to measure diluted samples. Refer to Rerunning a Test with a Diluted Sample in the System Help for more information.
Beckman Coulter suggests sharing the letter with a Medical Director to determine if performing a retrospective review of results is necessary.
This action has been closed out on 21/01/2026. |
| Action Commencement Date |
1/10/2025 |
| Responsible Entity |
|
| Contact Information |
1800 060 878 - Beckman Coulter Australia |