510(k) · Cleared
Recalled · Class II · 2025Alinity h-series System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Abbott Laboratories · GKZ Counter, Differential Cell
Cleared on Feb 20, 2025 as substantially equivalent to K220031 (Abbott Laboratories, 2023) after a 126-day review. Its family tree reaches back 4 generations to 2004. It has been recalled once.
- Decided
- Feb 20, 2025
- Review
- 126 days
- Class
- Class II
- Product code
- GKZ
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 4 generations to K040073 (2004). No later device cites it as a predicate yet.
- Root · 4 generations backK040073 Sysmex Automated Hematology Analyzer, XE-2100 Series (XE-2100…Sysmex America, Inc. · 2004
- 3 generations backK071967 Sysmex XE-5000Sysmex America, Inc. · 2007 · Recalled
- 2 generations backK112605 Sysmex XN-SeriesSysmex America, Inc. · 2012 · Recalled
- 1 generation backK220031 Alinity h-series SystemAbbott Laboratories · 2023 · Recalled
- This deviceK243283 Alinity h-series SystemAbbott Laboratories · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K040073 | Sysmex Automated Hematology Analyzer, XE-2100 Series (XE-2100, XE-2100L) | Sysmex America, Inc. | 2004 | — |
| −3 | K071967 | Sysmex XE-5000 | Sysmex America, Inc. | 2007 | 1 |
| −2 | K112605 | Sysmex XN-Series | Sysmex America, Inc. | 2012 | 2 |
| −1 | K220031 | Alinity h-series System | Abbott Laboratories | 2023 | 2 |
| 0 (this device) | K243283 | Alinity h-series System | Abbott Laboratories | 2025 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in GKZ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new GKZ device
- #1 K250943 Sysmex XR-Series (XR-10) Automated Hematology…score 13.2 · 3 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K220031 | Alinity h-series SystemSummary page 6…Page 1 of 29 IV. Predicate Device Alinity h-series System (K220031) V. Device Description The Alinity h-series System is a multimodule system that consists of different combinations of o… | 2023 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 18, 2025 | Class II | Z-0489-2026 | Software design | 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. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 21 years and passes through 2 companies; a new generation was cleared every 4.9 years on median.
- 3 of the 4 ancestors have a recall of any class.
How does its category compare?
All GKZ devicesGKZ Counter, Differential Cell: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · GKZ
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GKZ
108in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GKZ
1in 2025
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · GKZ
77in 2025
MAUDE reports naming product code GKZ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 6 | 117 | 37 | 268 |
| 2008 | 6 | 99 | 5 | 925 |
| 2009 | 6 | 147 | 13 | 559 |
| 2010 | 4 | 290 | 27 | 896 |
| 2011 | 3 | 315 | 28 | 2,905 |
| 2012 | 3 | 408 | 7 | 2,959 |
| 2013 | 1 | — | 6 | 3,070 |
| 2014 | 3 | 165 | 0 | 3,112 |
| 2015 | 3 | 273 | 3 | 1,972 |
| 2016 | 3 | 198 | 3 | 3,338 |
| 2017 | 4 | 280 | 3 | 229 |
| 2018 | 3 | 270 | 2 (2) | 497 |
| 2019 | 5 | 210 | 2 | 908 |
| 2020 | 1 | — | 1 | 342 |
| 2021 | 0 | — | 0 | 391 |
| 2022 | 3 | 638 | 4 | 198 |
| 2023 | 4 | 329 | 1 | 155 |
| 2024 | 3 | 157 | 0 | 115 |
| 2025 | 4 | 108 | 1 | 77 |
| 2026 | 4 | 254 | 0 | — |
What is it indicated for?
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 can be configured as: • One stand-alone 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…
Read the full statement (186 words)
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 can be configured as:
• One stand-alone 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K243283 · printed Nov 6, 2026
Cite this page
510(k) Report. “K243283: Alinity h-series System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K243283
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026