| TGA Action ID |
RC-2026-RN-00702-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
N Rheumatology Standard SL. An in vitro diagnostic medical device (IVD).
Material Number: 10446099
Lot Numbers: 183824B, 183824D, 183824H, 183828
Expiry Dates: 28/10/2026, 10/05/2027 |
| ARTG Number |
178155 |
| Unique Device Identifier (UDI) |
00842768007798 |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class III |
| Reason for the Action |
Siemens Healthineers identified that assigned values for certain lots of N Rheumatology Standard SL were not correctly aligned with the NIBSC International Reference Preparation for Rheumatoid Arthritis Serum (Code 64/002). As a result, assigned values for associated N/T Rheumatology Control SL/1 and N/T Rheumatology Control SL/2 lots were also affected.
This problem may cause rheumatoid factor (RF) patient results to exhibit an approximate positive bias of 20%, with quality control recoveries showing a positive bias of up to 30%. The problem is limited to the RF parameter and does not affect other assays. |
| Instructions for Customers/Users |
Customers are to:
- Identify affected lots currently in use.
- Implement the revised RF target values for all affected lots.
- Use the revised target values for future RF assay calibration and quality control activities.
- Be aware that implementation may result in a one-time negative shift in RF results. |
| Action Commencement Date |
16/09/2026 |
| Responsible Entity |
|
| Contact Information |
1800 310 300 - Siemens Customer Care Center |