Health product recall

Alinity HQ Analyzer

Last updated

Summary

Product
Alinity HQ Analyzer
Issue
Medical devices - Performance
What to do

Contact the manufacturer if you require additional information. 

Audience
Healthcare

Affected products

Affected products Lot or serial number Model or catalogue number
Alinity HQ Analyzer More 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.

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Haematology
Companies

Abbott Laboratories

4551 Great America Pkwy, Santa Clara, California, United States, 95054

Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Recall date
Identification number
RA-78175

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