| TGA Action ID |
RC-2025-RN-00779-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Atellica UAS 800 Urine Sediment Analyser. An in vitro diagnostic medical device (IVD)
Siemens Material Number: 11065004
Software Version: v4.0.510
Serial Numbers: All system s/n H101438 and above, built with software v4.0.510 and All system serial numbers upgraded to software v4.0.510 |
| ARTG Number |
175890 |
| Unique Device Identifier (UDI) |
00630414001357 |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
A problem has been confirmed with user-defined rules on the Atellica 1500 Automated Urinalysis System, a unit combining the CLINITEK Novus Urine Chemistry Analyser and the Atellica UAS 800 Urine Sediment Analyser. This problem occurs when operating on software version 4.0.510 with custom rules for blood enabled. There is no impact to the calculation of blood results on any of the aforementioned instruments.
The Atellica UAS 800 Analyser allows users to configure custom rules that define automated actions based on sample results. These rules can be applied to both chemistry and sediment results.
With software version 4.0.510, changes to the underlying logic for blood rules may lead to incorrect comments or unintended actions being applied to blood results received from the CLINITEK Novus Analyser. When custom rules for blood are enabled in software version 4.0.510, the following problems may occur, but are not limited to:
• Incorrect comment added to the result record
• Result unnecessarily held for operator review
• Auto-validation of a result that requires operator review
• Sediment analysis skipped when it is required
• Unnecessary sediment analysis ordered |
| Instructions for Customers/Users |
Siemens will contact customers to schedule the mandatory software update to fix the problem, which is now available.
In the interim, customers using custom rules on software v4.0.510, specifically for Blood, may decide to review all results for which incorrect Blood rules were applied. Refer to the Appendix in the Customer Letter for how the rules have been applied.
Affected customers can choose to disable rules until the software is updated, noting that disabling rules will result in purging existing samples from the result database.
This action has been closed out on 24/04/2026 |
| Action Commencement Date |
12/09/2025 |
| Responsible Entity |
|
| Contact Information |
1800 310 300 - Siemens Customer Care Centre |