| TGA Action ID |
RC-2026-RN-00907-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
DxC 500 AU Clinical Chemistry Analyzer and DxC 500i Clinical Analyzer. An in vitro diagnostic medical device (IVD).
Software: 1.5.0 and below
With ISE
Module: AU w/ISE
REF: C63520
Without ISE
Module: AU w/out ISE
REF: C63519 |
| ARTG Number |
177999 |
| Unique Device Identifier (UDI) |
14987666545065 , 14987666545058 |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
The sponsor identified an intermittent software problem that may cause incorrect Clinical Chemistry test results when non-default reporting units are used. When multiple tests or replicates are ordered under the same Sample ID, the software may apply the unit conversion factor more than once, resulting in falsely elevated or decreased results. |
| Instructions for Customers/Users |
Customers are to:
- Review the system configuration and follow the instructions provided in the customer letter.
- Arrange installation of the software update when contacted by Beckman Coulter. The software correction is expected to be available in Q4 2026. |
| Action Commencement Date |
11/11/2026 |
| Responsible Entity |
|
| Contact Information |
1800 060 878 - Beckman Coulter |