| TGA Action ID |
RC-2026-RN-00325-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Alinity hq, An in vitro diagnostic medical device (IVD).
List Number: 09P68-01
Impacted serial numbers: HQ00204, HQ00208, HQ00654, HQ00922, HQ00932 |
| ARTG Number |
388425 |
| Unique Device Identifier (UDI) |
(01)00380740138851(21)HQ00204, (01)00380740138851(21)HQ00208, (01)00380740138851(21)HQ00654, (01)00380740138851(21)HQ00922, (01)00380740138851(21)HQ00932 |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
A software problem has been identified in Alinity h-series software versions 5.10.1 and below that affects the measurement of a small subset of samples with bimodal Red Blood Cell (RBC) populations.
In affected samples, exclusion of the secondary RBC population may result in suspect or incorrect calculated parameters, including Mean Cell Volume (MCV), Red Blood Cell Distribution Width (RDW), Haematocrit (HCT), and Mean Cell Haemoglobin Concentration (MCHC). RBC counts and other parameters are not impacted.
To date, there have been no reports of impact to patient management. |
| Instructions for Customers/Users |
Customers are to:
- Continue to follow the interim instructions outlined in the customer letter.
- Implement the software upgrade once it is released to resolve the identified problem.
This action has been finalised on 04/11/2026. |
| Action Commencement Date |
5/05/2026 |
| Responsible Entity |
|
| Contact Information |
1800 816 696 - Abbott Customer Support |