| TGA Action ID |
RC-2026-RN-00079-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Beckman Coulter DxC 700 AU and Chemistry Analyzer AU5800. An in vitro diagnostic medical device (IVD).
REF: B86443, B86444, B86445, B86446, C88431, C88432, B96697, B96698, C88433, C88434, A94914, B23279, B23280, B23281
Multiple serial numbers |
| ARTG Number |
177999 |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class I |
| Reason for the Action |
The analysers may unexpectedly generate the below errors when transitioning from Standby to Measure 1, or from Measure 2 to Measure 1, when using PC pre-installed with Microsoft SQL Server 2022 Express:
• 9000 PROGRAM ERROR (... CAL History DB Open Error.(SqlErr) ...)
• 9000 PROGRAM ERROR (... RB History DB Open Error.(SqlErr) ...)
These errors are caused by the inability to open the Regent Blank (RB) and Calibration databases. If this problem occurs, the system will stop analysing, and a Beckman Coulter Field Service Engineer (FSE) visit is required to restore the system.
This problem occurs when the Calibration Monitor remains open for more than 15 minutes.
This problem may cause a delay in reporting of patient results, and thus delay in diagnosis and/or patient treatment. It does not cause incorrect test results. |
| Instructions for Customers/Users |
A Beckman Coulter field engineer will visit on-site and install a software update to impacted systems. Until the software update is installed, customers should do the following:
- Do not leave the Calibration Monitor open for more than 15 minutes (including the five tabs under the Calibration tab)
- Perform the system shutdown (END Process) daily.
- For AU5800, ensure the backup checkbox is selected during system shutdown. DxC 700 AU does not have a checkbox as backup is done automatically during shutdown. |
| Action Commencement Date |
3/02/2026 |
| Responsible Entity |
|
| Contact Information |
1800 060 878 - Beckman Coulter Customer Service |