| TGA Action ID |
RC-2026-RN-00662-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Atellica CH Revised C Reactive Protein (RCRP). An in vitro diagnostic medical device (IVD)
Test Code: RCRP
All lots |
| ARTG Number |
175075 |
| Unique Device Identifier (UDI) |
00630414610887 |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class III |
| Reason for the Action |
Siemens Healthineers has confirmed through the investigation of customer complaints the potential for falsely elevated results when the Atellica CH Revised C-Reactive Protein (RCRP) assay is used on the Atellica CH and Atellica CI analyzers.
A small subset of samples may reproducibly generate one of the following outcomes:
1. A falsely elevated, reportable result.
2. An initial falsely elevated result above the measuring interval (>25.00 mg/dL or >250.0 mg/L), followed by a 5X auto-diluted result that is inconsistent with the initial result. In this scenario, the auto-diluted result is non-reportable and flagged with “Conc Error” or “< Measuring Interval”.
Depending on the scenario, this problem may result in either:
- An erroneously elevated, unflagged result; or
- A delay in obtaining a final reportable result when the system generates a flagged, non-reportable result. |
| Instructions for Customers/Users |
Customers are to:
- Follow the instructions outlined in the Customer Letter to correct the product.
- Record the number of unused tests discarded on the Response Form for reimbursement or credit.
- Review the Customer Letter with a Medical Director to determine the appropriate course of action, including for any previously generated results, if applicable. |
| Action Commencement Date |
31/08/2026 |
| Responsible Entity |
|
| Contact Information |
1800 310 300 - Siemens Customer Care Centre |