| TGA Action ID |
RC-2025-RN-00546-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
ADVIA 120/2120/2120i Haematology System components. An in vitro diagnostic medical device (IVD)
SETpoint Calibrator
Lot numbers: SP251033, SP251043
TESTpoint Control (ABN1)
Lot numbers: TP251035, TP251045
TESTpoint Control (Normal)
Lot numbers: TP252035, TP252045
TESTpoint Control (ABN2)
Lot numbers: TP253035, TP253045 |
| ARTG Number |
184193 |
| Unique Device Identifier (UDI) |
Refer to customer letter (multiple products) |
| Action Type |
Recall |
| Action Level |
Hospital |
| Hazard Classification |
Class III |
| Reason for the Action |
There is the potential for incorrect platelet (PLT) value assignments for certain Setpoint Calibrator and Testpoint Control lots used with the ADVIA 120/2120/2120i Haematology Systems. Low Bias for Patient Platelet Values and High Control Values for Platelets.
Erroneously decreased patient platelet results may be reported if calibrator SETpoint lot SP251033 or SP251043 are used, and controls are recovering within the expected assigned value ranges. Siemens’ investigation revealed a deviation of up to -18% in patient results across the assay range when these calibrators are used. |
| Instructions for Customers/Users |
Discontinue use of and discard the calibrator SETPOINT lots SP251033 and SP251043. Customers experiencing this problem should request a credit from Siemens.
Customers that have calibrated using SETPOINT lots SP251033 or SP251043 should perform a calibration using a subsequent lot. Customers that have not calibrated using SETPOINT lot SP251033 or SP251043 do not need to perform additional calibration.
Controls with PLT results that are within the expected assigned value ranges may continue to be used.
Customers who observe PLT results that are consistently out of the expected assigned value ranges for the above TESTpoint lots should discontinue use of and discard them, and request a credit from Siemens.
Customers should review with their Medical Director to determine appropriate actions for any previously generated results, if applicable.
This action has been finalised on 19/9/2025. |
| Action Commencement Date |
19/06/2025 |
| Responsible Entity |
|
| Contact Information |
1800 310 300 - Siemens Customer Care Center |