| TGA Action ID |
RC-2026-RN-00144-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Atellica CH Enzymatic Hemoglobin A1c (A1c_E). An in vitro diagnostic medical device (IVD)
Test code: A1c_E & A1c_H
Siemens Material Number: 11097536
All lots |
| ARTG Number |
176642 |
| Unique Device Identifier (UDI) |
00630414220505 |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
Siemens Healthineers has identified a problem with the Atellica CH Enzymatic Hemoglobin A1c (A1c_E) assay, where A1c results can be falsely depressed and imprecise when the Revised C-Reactive Protein (RCRP) assay is run on the same analyser. This effect increases over time and with higher RCRP testing volumes and may affect both quality control (QC) and patient results.
Siemens Healthineers is investigating the root cause and the resolution for this problem. |
| Instructions for Customers/Users |
Customers are to:
- Confirm whether RCRP and A1c_E are processed on the same analyser; if not, no action is required.
- If processed on the same analyser, monitor A1c_E QC for negative bias and increased imprecision. |
| Action Commencement Date |
26/02/2026 |
| Responsible Entity |
|
| Contact Information |
1800 310 300 - Siemens Customer Care Centre |