Recall Monitor
Health Products

Alinity HQ Analyzer

· Published by Health Canada · Official notice

Details

Alert type: Health product recall
Category: Health products - Medical devices - Haematology
Product: Alinity HQ Analyzer
Issue: Medical devices - Performance
What to do: Contact the manufacturer if you require additional information.
Audience: Healthcare
Recall class: Type II
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Products

Affected productsLot or serial numberModel or catalogue number
Alinity HQ AnalyzerMore than 10 numbers, contact manufacturer.09P68-01

Issue

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.

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