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Alinity hq analyzer
Official notice
2 Oct 2025
Last checked
2 Oct 2025
An official Health Canada notice concerns Alinity hq analyzer. An issue has been identified in Alinity HQ Analyzer software versions 5.0 to 5.10.1. The immature granulocyte saturation (IG sat) flag is intended to indicate a high number of saturated events that impact the IG/%IG and neutrophils (NEU/%NEU) parameters. However, the system does not visibly apply appropriate flagging to IG/%IG and NEU/%NEU results when saturation is present, which may prevent users from recognizing potentially impacted values. When IG sat is present, NEU is the most likely to be affected. Additionally, because white blood cell (WBC) differential results must total 100%, any distortion in IG values may also affect other parameters-such as basophils (BASO), monocytes (MONO), lymphocytes (LYM), and eosinophils (EOS) -potentially leading to inaccurate distribution across the full wbc differential. A new software version for the Alinity HQ analyzer to resolve this issue is expected to be available in 2026. Your Abbott representative will contact you to schedule a mandatory upgrade. Published 2025-10-02.
What to do now
Contact the manufacturer if you require additional information.
Recall number
78175
Official notice
2025-10-02
The hazard
The hazard
An issue has been identified in Alinity HQ Analyzer software versions 5.0 to 5.10.1. The immature granulocyte saturation (IG sat) flag is intended to indicate a high number of saturated events that impact the IG/%IG and neutrophils (NEU/%NEU) parameters. However, the system does not visibly apply appropriate flagging to IG/%IG and NEU/%NEU results when saturation is present, which may prevent users from recognizing potentially impacted values. When IG sat is present, NEU is the most likely to be affected. Additionally, because white blood cell (WBC) differential results must total 100%, any distortion in IG values may also affect other parameters-such as basophils (BASO), monocytes (MONO), lymphocytes (LYM), and eosinophils (EOS) -potentially leading to inaccurate distribution across the full wbc differential. A new software version for the Alinity HQ analyzer to resolve this issue is expected to be available in 2026. Your Abbott representative will contact you to schedule a mandatory upgrade.
How to check if you're affected
How to check if you're affected
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Company & contacts
Company & contacts
Brand: Abbott Laboratories, Alinity Hq Analyzer.
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Documents, notices & source
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