| TGA Action ID |
RC-2026-RN-00675-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
DxC 500 AU Clinical Chemistry Analyser & DxC 500i Clinical Analyser. An in vitro diagnostic medical device (IVD).
DxC 500 AU w/ISE
REF: C63520
DxC 500 AU w/out ISE
REF: C63519
DxC 500 AU Module w/ISE, DxC 500i
REF: C63522
DxC 500 AU Module, DxC 500i
REF: C63521 |
| ARTG Number |
177999 |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
Beckman Coulter has identified a software problem affecting DxC 500 AU Clinical Chemistry Analyser and DxC 500i Clinical Analyser when testing plasma samples.
Following user configuration of a Clinical Chemistry test to use units different from the system default, a subsequent configuration change and activation of the draft configuration in the System Configuration page may cause the analyser to revert the test units to the system default setting without notifying the user.
The system does not provide a warning or notification to alert the user that the configured units have reverted to the default units.
This problem may cause falsely elevated results for selected Chemistry assays due to unintended reversion to default units, which may lead to unnecessary medical treatment and additional non-invasive testing. |
| Instructions for Customers/Users |
Customers should note:
•For analysers on software versions earlier than 1.5:
o Users should verify that their instrument displays the intended units in the Test Menu page within the System Configuration page prior to reporting patient results.
o Beckman Coulter recommends posting this letter on or near the affected analysers if you have the affected software version, as well as sharing the content of the customer letter with their laboratory and/or medical director to assess laboratory and patient impact.
• This problem is resolved in software version 1.5.
• If your analyser is currently operating on a software version earlier than version 1.5, a Beckman Coulter service representative will contact customers to schedule the upgrade to software version 1.5. |
| Action Commencement Date |
9/09/2026 |
| Responsible Entity |
|
| Contact Information |
1800 060 878 - Customer Administration Services |