| TGA Action ID |
RC-2026-RN-00211-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Atellica CH Creatine Kinase (CK_L). An in vitro diagnostic medical device (IVD).
Siemens Material Number: 11097640
Lot Numbers: 252591, 252602, 252612
Expiry Date: 01/08/2026 & 01/09/2026 |
| ARTG Number |
176331 |
| Unique Device Identifier (UDI) |
00630414006642 |
| Action Type |
Recall |
| Action Level |
Hospital |
| Hazard Classification |
Class III |
| Reason for the Action |
Siemens Healthineers has confirmed, through investigation of customer complaints, the potential for falsely elevated patient, quality control (QC), and/or calibrator results when using Atellica CH Creatine Kinase (CK_L) affected lot numbers on the Atellica CH and Atellica CI Analyzers. This problem may be observed with both serum and plasma sample types. QC results may or may not detect the problem.
Falsely elevated results may lead to additional follow-up diagnostic laboratory testing. |
| Instructions for Customers/Users |
Customers are to:
- Immediately discontinue use of and discard the affected kit lots.
- Review the Customer Letter with a Medical Director to determine the appropriate course of action, including for any previously generated results, if applicable.
- Review inventory of these products to determine replacement needs and to provide information to Siemens Healthineers for regulatory reporting.
This action has been closed out on 16/06/2026 |
| Action Commencement Date |
24/03/2026 |
| Responsible Entity |
|
| Contact Information |
1800 310 300 - Siemens Customer Care Centre |