CanadaWhat's being recalled
Companies: Abbott Laboratories, 4551 Great America Pkwy, Santa Clara, California, United States, 95054.
How to identify it
Affected products: Alinity HQ Analyzer; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 09P68-01
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.
What to do
Contact the manufacturer if you require additional information.
The official notice
This page is a summary of the notice published by Health Canada, collected from Health Canada, CFIA and Transport Canada. Check the original before you act on it.
Read the official notice (opens in a new tab)
United States