| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00502-1 |
| Product Name/Description |
Alinity hq Analyzer. An in vitro diagnostic medical device (IVD)
List number: 09P68-01
Serial Numbers: HQ00922, HQ00932, HQ00204 HQ00208, HQ00654
ARTG 388425
(Abbott Australasia Pty Ltd Diagnostic Division - Instrument/analyser IVDs) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
18/06/2024 |
| Responsible Entity |
|
| Reason/Issue |
Abbott has identified the following problems when using Alinity hq Analyzer software version 5.6 and below which will be corrected in software version 5.8.
- Problem 1:
When processing a CBC+DIFF sample that immediately follows a CBC+DIFF+RETIC sample, diluent may backflow into the RBC dilution cup. This may result in falsely low Red Blood Cell (RBC) results and consequently falsely high Mean Cell Hemoglobin Concentration (MCHC), falsely high Mean Cell Hemoglobin (MCH), and falsely low Hematocrit (HCT).
- Problem 2:
An overestimation of the basophil (BASO) count may occur on some samples when cell events are incorrectly counted as BASO during sample analysis. This may result in falsely increased BASO counts and %B (%BASO).
Alinity hq software version 5.8 is scheduled to be released in June 2024.
No Adverse events due to this problem have been reported in Australia. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
- An Abbott representative will be scheduling a mandatory upgrade of Alinity hq Analyzer to install software version 5.8 to prevent these potential problems and improve the system.
- In the meantime customers are to follow instructions outlined in the Customer Letter to mitigate potential risks associated with Problem 1 and 2. |
| Contact Information |
1800 816 696 - Abbott Customer Support |