| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00212-1 |
| Product Name/Description |
Atellica CH analysers. An in vitro diagnostic medical device (IVD)
Atellica CH Iron3
Material number: 11537211
UDI: 00630414610849
Lot number: All
ARTG 176642
(Siemens Healthcare Pty Ltd - Clinical chemistry substrate IVDs) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
15/03/2024 |
| Responsible Entity |
|
| Reason/Issue |
Siemens Healthineers has confirmed the potential for falsely elevated Chol_2, LDLC, and Trig_2 results on the Atellica CH and Atellica CI analysers when the previous reagent in the cuvette was Iron3. This problem can impact calibrator, quality control (QC), and patient results.
The Atellica CH HDL Cholesterol (HDLC) and Atellica CH Iron_2 (Iron_2) assays are not impacted by this problem. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Customers should:
1. Review the customer letter with their Medical Director to determine the appropriate course of action, including for any previously generated results, if applicable.
2. Refer to short-term mitigation steps in “Appendix B” of the customer letter while Siemens works towards transitioning customers back to the Iron_2 assay.
Siemens is actively working to ramp up the supply volume to support customer conversion to the Iron_2 assay. |
| Contact Information |
1800 310 300 -Siemens Customer Care Centre or Matt Kay, Product Specialist- 0438 399 217 |