| TGA Action ID |
RC-2025-RN-00973-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
CLINITEK Novus Automated Urine Chemistry Analyser. An in vitro diagnostic medical device (IVD).
Software Version: v1.4.1
Material Number: 10697937
UDI-DI: 00630414981147 |
| ARTG Number |
175890 |
| Unique Device Identifier (UDI) |
00630414981147 |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
Siemens Healthineers has confirmed through complaint investigation, a software problem affecting the Atellica 1500 Control Checks when using third-party (non-Siemens Healthineers) controls. The Atellica 1500 Automated Urinalysis System is a system that connects the CLINITEK Novus Urine Chemistry Analyser and the Atellica UAS 800 Urine Sediment Analyser.
The problem stems from Novus quality control limits being linked to the wrong configuration. When Control Check Limits are enabled, the system incorrectly applies the Chemistry Only mode's control limits to the Chemistry + Sediment checks. This problem affects only CLINITEK Novus software v1.4.1 when used in conjunction with the Atellica 1500 Automated Urinalysis System, and when third-party controls are used for the Chemistry + Sediment control workflow with Control Check enabled.
The upcoming CLINITEK Novus software version 1.4.2 will include a fix for the Quality Control problem. No injuries have been reported to date. |
| Instructions for Customers/Users |
Siemens will coordinate the update for all affected customers. Until the software update becomes available, customers may take one of the following actions to mitigate the problem:
o Option 1: Disable the Chemistry + Sediment control workflow and use Chemistry Only. Follow the steps provided in Appendix “Select Control Workflow to Chemistry Only”.
o Option 2: Disable Control Checks when using the Chemistry + Sediment control workflow. Follow the steps provided in Appendix “Disable Control Checks”. Use the third party’s specified control value assignments to manually verify the quality control results.
This action has been closed out on 30/04/2026. |
| Action Commencement Date |
17/11/2025 |
| Responsible Entity |
|
| Contact Information |
1800 310 300 - Siemens Customer Care |