| TGA Action ID |
RC-2026-RN-00442-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Atellica CH Enzymatic Haemoglobin A1c (A1c_E) used with Atellica CH and Atellica CI systems. An in vitro diagnostic medical device (IVD).
Test Codes: A1c_E, A1c_H
Material Number: 11097536
All in-date lots |
| ARTG Number |
176642 |
| Unique Device Identifier (UDI) |
00630414220505 |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
There is the potential for intermittent well-to-well bias affecting the A1c_E and A1c_H assays when used on the Atellica CH and Atellica CI systems.
This problem may result in:
· Falsely depressed patient results when lot calibration is performed using an affected well and patient testing is subsequently performed using an unaffected well.
· Falsely elevated patient results when lot calibration is performed using an unaffected well and patient testing is subsequently performed using an affected well. |
| Instructions for Customers/Users |
Customers are to perform QC on each reagent well used for all A1c_E/A1c_H testing.
Further information is provided in the customer letter regarding enabling QC and monitoring QC results.
In the event of QC failure:
o Unload the reagent pack and load a new pack.
o Repeat QC testing.
o After acceptable QC results have been obtained, repeat any held A1c_E/A1c_H samples since the failed QC event.
Report additional and/or discarded A1c_E/A1c_H tests or wells to Siemens Healthineers for credit. |
| Action Commencement Date |
11/06/2026 |
| Responsible Entity |
|
| Contact Information |
1800 310 300 - Siemens Customer Care Centre |