| TGA Action ID |
RC-2025-RN-00744-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Atellica CH Urinary/Cerebrospinal Fluid Protein Assay. An in vitro diagnostic medical device (IVD).
Test Code: UCFP
Material Number: 11097543
UDI: 00630414279206
Lot Numbers: All |
| ARTG Number |
175075 |
| Unique Device Identifier (UDI) |
00630414279206 |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
Siemens confirms the potential for falsely depressed patient, quality control (QC), and/or calibration results. The observations have been isolated to the initial replicate(s) of a freshly punctured Atellica CH UCFP reagent well that has been stored onboard the system.
The problem is intermittent and will not occur in all packs or wells. The problem may be observed with all sample types (urine and cerebrospinal fluid) for any Atellica CH UCFP reagent lot on an Atellica CH or CI analyzer.
Siemens is working to determine root cause and restore the assay performance. |
| Instructions for Customers/Users |
Customers are to:
- As an interim measure, keep only one (1) Atellica CH UCFP reagent pack onboard the system at a time.
- Unload any Atellica CH UCFP packs that are currently onboard the system.
- Perform QC on each well following instructions provided in the Customer Letter.
- Review this letter with the Medical Director to determine the appropriate course of action, including for any previously generated results, if applicable.
- Siemens Healthineers will provide a credit for the additional reagent consumption (number of tests) once reported. |
| Action Commencement Date |
1/09/2025 |
| Responsible Entity |
|
| Contact Information |
1800 310 300 - Siemens Customer Care Center |