| TGA Action ID |
RC-2026-RN-00536-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
DxC 500 AU and DxC 500i Clinical Chemistry Analyzer. An in vitro diagnostic medical device (IVD).
Software Version: 1.5 or lower
Reference Numbers: C63520, C63519, C63522, C63521
Analyzer Modules: AU w/ISE; AU w/out ISE; DxC 500 AU Module w/ISE, DxC 500i; DxC 500 AU Module, DxC 500i |
| ARTG Number |
177999 |
| Unique Device Identifier (UDI) |
14987666545065, 14987666545058, 14987666545089, 14987666545072 |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
Beckman Coulter has determined that a modification made by operators to 25 predefined calculated rules, which are included as part of the parameter package, will revert to the default expression following parameter package or software upgrades.
The problem may cause operator-modified predefined calculation rules to revert to their default settings following a software or parameter package upgrade, potentially resulting in unexpected calculated results. The risk depends on the assays involved and the extent of the rule modifications, with the worst-case scenario being an incorrect assessment of an elevated anion gap, which could lead to inappropriate treatment or delayed diagnosis.
The problem only affects the specific predefined rules identified and does not impact other chemistry rules or rules configured and run through host systems.
To date, no adverse events have been reported due to this problem. |
| Instructions for Customers/Users |
Customers are to:
• Not change any of the 25 predefined calculated rules. In the case that the default expression does not meet the laboratory’s requirements, Beckman Coulter has developed a Job Aid which outlines the workflow required if laboratories require calculated test rules outside of the predefined rules.
• Consult with the Laboratory Manager and/or Medical Director to determine whether any of the predefined rules in the table were modified from the default expression during or following analyser installation.
o If no default expression was modified, there is no action to be taken.
o If a predefined calculated rule was modified, follow the steps in the Customer Letter to configure this rule as a custom calculated rule in System configuration and to disable the predefined calculated rule that was modified.
• Determine if performing a retrospective review of results is necessary.
Beckman Coulter is currently investigating this problem and will contact customers once a software update to correct the problem is available. |
| Action Commencement Date |
17/07/2026 |
| Responsible Entity |
|
| Contact Information |
1800 060 878 - Beckman Coulter |