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Health Canada Medical devices

Alinity HQ Analyzer

Issued July 5, 2024
Issue
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
Hazard description
Performance
Product
Product name
Alinity HQ Analyzer
Reference
ID
RA-75791