# K220031: Alinity h-series System

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Laboratories
- Decided: Aug 4, 2023 after 576 days
- Product code: GKZ (Counter, Differential Cell)
- Device class: 2
- Regulation: 21 CFR 864.5220
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K040073 (2004). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112605: Sysmex XN-Series, Sysmex America, Inc. (2012) Summary page 5.

## Most influential descendants
- K243283: Alinity h-series System (2025), 0 descendants of its own

## Recalls of this device
- Sep 18, 2025 · Class II · Z-0489-2026: Software issue for hq analyzer results in system not visibly applying appropriate flagging to results when saturation is present which may result in incorrect results.
- Jun 14, 2024 · Class II · Z-2681-2024: 1)If Complete Blood Count with differential and reticulocyte(CBC+Diff+Retic) sample is run, then immediately following on same rack CBC+Diff sample is run, then falsely low red blood cell count may oc

## Indications for use
The Alinity h-series System is an integrated hematology analyzer (Alinity hq) and slide maker stainer (Alinity hs) intended for screening patient populations found in clinical laboratories by qualified health care professionals. The Alinity h-series System can be configured as: • One standalone automated hematology analyzer system. • A multimodule system that includes at least one Alinity hq analyzer module and may include one Alinity hs slide maker stainer module. The Alinity hq analyzer module provides complete blood count and a 6-part white blood cell differential for normal and abnormal cells in capillary and venous whole blood collected in K2EDTA or K3EDTA. The Alinity hq analyzer provides quantitative results for the following measurands: WBC, NEU, %N, LYM, %L, MON, %M, EOS, %E, BASO, %B, IG, %IG, RBC, HCT, HGB, MCV, MCH, MCHC, MCHr, RDW, NRBC, NR/W, RETIC, %R, IRF, PLT, MPV, %rP. The Alinity hq analyzer module is indicated to identify patients with hematologic parameters within and outside of established reference ranges. The Alinity hs slide maker stainer module automates whole blood film preparation and staining and stains externally prepared whole blood smears. For in-vitro diagnostic use.

Source page: https://510kreport.com/device/K220031
Methodology: https://510kreport.com/methodology