Official recall record
Alinity HQ Analyzer (ref 75791)
- Issuing authority
- Health Canada — Medical Devices
- Published
- 2024-07-05
- Country of alert
- Canada
- Alert level
- Type II
- Alert type
- recall
What the authority reported
Abbott has identified the following issues when using Alinity HQ Analyzer software version 5.6 and below which will be corrected in software version 5.9. Issue 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). Issue 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). Recall start date: June 21, 2024
What to do
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Record last checked against the registry on 2026-05-31.