| TGA Action ID |
RC-2025-RN-00731-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
UniCel DxH Coulter Cellular Analysis Systems configured with LED HGB Photometer. An in vitro diagnostic medical device (IVD)
Part Numbers:
C11478 - UniCel DxH 900 Coulter Cellular Analysis System
C34520 - UniCel DxH 690T Coulter Cellular Analysis System
B24802, 629029, B63322 - UniCel DxH 800 Coulter Cellular Analysis System
B23858 - UniCel DxH 600 Coulter Cellular Analysis System
D03377 - FRU LED HGB PHOTOMETER
Multiple Serial Numbers |
| ARTG Number |
177999 |
| Unique Device Identifier (UDI) |
Refer to attached UDI list |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
There is the potential for erroneously high Hemoglobin (HGB) results on samples with elevated White Blood Cell (WBC) counts. This may occur on UniCel DxH Series instruments configured with the LED HGB Photometer.
This problem was identified following a complaint where a patient sample with a WBC count of approximately 300 x 10³ cells/µL generated a falsely elevated HGB by 1.6 g/dL and MCHC by 5.5 g/dL.
Falsely elevated HGB results may be observed in specimens with WBC counts > 30 x 10³ cells/µL. The HGB bias increases proportionally with rising WBC concentrations. |
| Instructions for Customers/Users |
Customers are to take the following actions for specimens with a WBC count > 30 x 10³ and = 90 x 10³ cells/µL to obtain accurate HGB results:
- Process specimens on an instrument not impacted by this action.
- Process specimens using a validated alternative method for HGB and associated parameters.
- Dilute specimens to below 30 x 10³ cells/µL using their laboratory protocol or the DxH predilute function. Refer to your instrument’s Instructions for Use (IFU), Chapter 5, Predilute Panel (PREDIx5) for detailed steps.
For specimens with a WBC count > 90 x 10³ cells/µL:
- Process specimens on an instrument not impacted by this action.
- Process specimens using a validated alternative method for HGB and associated parameters.
Customers should refer to the customer letter for further instructions, and consult their Medical Director to determine if a retrospective review of results is warranted. |
| Action Commencement Date |
27/08/2025 |
| Responsible Entity |
|
| Contact Information |
1800 060 878 - Beckman Coulter Customer Service |