510(k) · Cleared
Recalled · Class I · 2019Unicel DXH 800 Coulter Cellular Analysis System/ Unicel DXH Slidemaker Stainer Coulter Cellular Analysis System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Beckman Coulter, Inc. · GKZ Counter, Differential Cell
Cleared on Sep 5, 2014 as substantially equivalent to K120771 (Beckman Coulter, Inc., 2013) after a 149-day review. Its family tree reaches back 1 generation to 2013. 1 of the 8 devices in its family, counting itself, has a Class I recall. 6 later devices descend from it. It has been recalled 17 times, including 3 Class I recalls.
- Decided
- Sep 5, 2014
- Review
- 149 days
- Class
- Class II
- Product code
- GKZ
- Recalls
- 17 (3 Class I)
- Predicates
- 1
Its longest line of descent runs back 1 generation to K120771 (2013). 6 later devices descend from it, 5 citing it directly. 1 of the 8 devices in this family, counting this one, has a Class I recall.
- Root · 1 generation backK120771 Unicel DXH 800 Coulter Cellular Analysis SystemBeckman Coulter, Inc. · 2013 · Recalled
- This deviceK140911 Unicel DXH 800 Coulter Cellular Analysis System/ Unicel DXH…Beckman Coulter, Inc. · 2014
- Descendant · cites it directly · 1 of its ownK193124 Unicel DxH 800 Coulter Cellular Analysis SystemBeckman Coulter · 2020 · Recalled
- Descendant · cites it directly · 1 of its ownK162414 UniCel DxH SlideMaker Stainer Coulter Cellular Analysis SystemBeckman Coulter, Inc. · 2016
- Descendant · 2 generations on · 0 of its ownK240252 UniCel DxH 900 Coulter Cellular Analysis System; UniCel DxH…Beckman Coulter, Inc. · 2024 · Recalled
- Descendant · cites it directly · 0 of its ownK230878 QScout Lab; QScout RLDAd Astra Diagnostics, Inc. · 2023
- Descendant · cites it directly · 0 of its ownK181475 DxH 520 Hematology InstrumentBeckman Coulter · 2019
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K193124Unicel DxH 800 Coulter Cellular Analysis SystemBeckman Coulter · 2020 · cites it directly1descendant
- K162414UniCel DxH SlideMaker Stainer Coulter Cellular Analysis SystemBeckman Coulter, Inc. · 2016 · cites it directly1descendant
- K240252UniCel DxH 900 Coulter Cellular Analysis System; UniCel DxH Slidemaker Stainer II…Beckman Coulter, Inc. · 2024 · 2 generations on0descendants
- K230878QScout Lab; QScout RLDAd Astra Diagnostics, Inc. · 2023 · cites it directly0descendants
- K181475DxH 520 Hematology InstrumentBeckman Coulter · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K120771 | Unicel DXH 800 Coulter Cellular Analysis System | Beckman Coulter, Inc. | 2013 | 11 |
| 0 (this device) | K140911 | Unicel DXH 800 Coulter Cellular Analysis System/ Unicel DXH Slidemaker Stainer… | Beckman Coulter, Inc. | 2014 | — |
| +1 | K193124 | Unicel DxH 800 Coulter Cellular Analysis System | Beckman Coulter | 2020 | 1 |
| +1 | K162414 | UniCel DxH SlideMaker Stainer Coulter Cellular Analysis System | Beckman Coulter, Inc. | 2016 | — |
| +2 | K240252 | UniCel DxH 900 Coulter Cellular Analysis System; UniCel DxH Slidemaker Stainer… | Beckman Coulter, Inc. | 2024 | 2 |
| +1 | K230878 | QScout Lab; QScout RLD | Ad Astra Diagnostics, Inc. | 2023 | — |
| +1 | K181475 | DxH 520 Hematology Instrument | Beckman Coulter | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
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.
1 device in this family has a Class I recall. 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? (2)
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 |
|---|---|---|---|
| * | K120771 | Unicel DXH 800 Coulter Cellular Analysis SystemSummary page 7…Number Cleared Code UniCel® DxH 800 Coulter® March K120771 Class II 864.5220 GKZ Cellular Analysis System 22, 2013 Manually prep… | 2013 |
| * | — | Manually prepared blood films per the manual wedge-pull film technique as described in… Named without a submission number |
What descends from it? (6)
5 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K193124 | Unicel DxH 800 Coulter Cellular Analysis System | 2020 | 1 |
| K162414 | UniCel DxH SlideMaker Stainer Coulter Cellular Analysis System | 2016 | 1 |
| K230878 | QScout Lab; QScout RLD | 2023 | 0 |
| K181475 | DxH 520 Hematology Instrument | 2019 | 0 |
| K141932 | Aquios CL Flow Cytometer, Aquios Tetra-1 Panel,Aquios Tetra-2+Panel, Aquios Immuno-Trol… | 2015 | 0 |
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 7, 2019 | Class II | Z-0516-2020 | Under Investigation by firm | When the UniCel DxH Slidemaker Stainer and UniCel DxH Slidemaker Stainer II dispense probe is slightly bent, there is a potential for cell carryover from the previous sample, and erroneous results could be reported from the slide review.… |
| Jul 30, 2018 | Class I | Z-1383-2019 | Software Design Change | Complaints received of sporadic erroneously elevated platelet results without flags or system messages. Thrombocytopenia may go unrecognized. |
| Jul 30, 2018 | Class I | Z-1384-2019 | Software Design Change | Complaints received of sporadic erroneously elevated platelet results without flags or system messages. Thrombocytopenia may go unrecognized. |
| Jul 30, 2018 | Class I | Z-1382-2019 | Software Design Change | Complaints received of sporadic erroneously elevated platelet results without flags or system messages. Thrombocytopenia may go unrecognized. |
| Nov 3, 2017 | Class II | Z-0237-2018 | Device Design | The shield for the Single-Tube Station on the DxH instrument may interfere with sample aspiration in the open vial position. |
| Nov 3, 2017 | Class II | Z-0238-2018 | Device Design | The shield for the Single-Tube Station on the DxH instrument may interfere with sample aspiration in the open vial position. |
| Nov 3, 2017 | Class II | Z-0236-2018 | Device Design | The shield for the Single-Tube Station on the DxH instrument may interfere with sample aspiration in the open vial position. |
| Jun 20, 2017 | Class II | Z-3101-2017 | Employee error | The firm has identified that a fitting in some Slidemaker Stainer units may not completely seal after installation. |
| Apr 24, 2017 | Class II | Z-2158-2017 | Device Design | There is a possibility of a data acquisition disruption that may cause an unusual light scatter event pattern for the white blood cell differential that may not have a system flag and/or message. The events associated with the unusual… |
| Apr 24, 2017 | Class II | Z-2157-2017 | Device Design | There is a possibility of a data acquisition disruption that may cause an unusual light scatter event pattern for the white blood cell differential that may not have a system flag and/or message. The events associated with the unusual… |
| Dec 19, 2016 | Class II | Z-1013-2017 | Under Investigation by firm | Beckman Coulter has determined that additional clarification for the Blast Suspect messages is necessary. In rare situations, the UniCel DxH 800 and DxH 600 Coulter Cellular Analysis System may not flag or detect blasts in some blood… |
| Dec 19, 2016 | Class II | Z-1014-2017 | Under Investigation by firm | Beckman Coulter has determined that additional clarification for the Blast Suspect messages is necessary. In rare situations, the UniCel DxH 800 and DxH 600 Coulter Cellular Analysis System may not flag or detect blasts in some blood… |
| Aug 8, 2016 | Class II | Z-2732-2016 | Software design | There is a possibility of specimen misidentification for the stand-alone DxH 800 and DxH 600 where the Primary Identifier is configured to Tube Position ID. |
| Aug 4, 2016 | Class II | Z-2692-2016 | Under Investigation by firm | Beckman Coulter is recalling the UniCel DxH Slidemaker Stainer Coulter Cellular Analysis System to reduce the potential for flammable liquids coming into contact with electrical components in the Stainer module possibly causing a fire. |
| Dec 1, 2015 | Class II | Z-0433-2016 | Software design | Beckman Coulter is recalling the DxH 800 Slidemaker Stainer Software version 3.0.2.0 and DxH 600 software version 1.1.1.0 because the software for the DxH systems allows the creation of multiple orders with the same Specimen… |
| Dec 1, 2015 | Class II | Z-0434-2016 | Software design | Beckman Coulter is recalling the DxH 800 Slidemaker Stainer Software version 3.0.2.0 and DxH 600 software version 1.1.1.0 because the software for the DxH systems allows the creation of multiple orders with the same Specimen… |
| Dec 1, 2015 | Class II | Z-0432-2016 | Software design | Beckman Coulter is recalling the DxH 800 Slidemaker Stainer Software version 3.0.2.0 and DxH 600 software version 1.1.1.0 because the software for the DxH systems allows the creation of multiple orders with the same Specimen… |
The 5 latest of 17 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has a recall.
- Of its descendants, K193124 (Beckman Coulter, 2020) has gone furthest, with 1 descendant of its own.
How does its category compare?
All GKZ devicesGKZ Counter, Differential Cell: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 UniCel® DxH 800 Analyzer is a quantitative multi-parameter, automated hematology analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories. The UniCel® DxH 800 Analyzer identifies and enumerates the parameters indicated below on the following sample types: Whole Blood (venous and capillary) - WBC, RBC, HGB, HCT, MCV, MCH, MCHC, RDW, RDW-SD, PLT, MPV, NE%, NE#, LY%, LY#, MO%, MO#, EO%, EO#, BA%, BA#, NRBC%…
Read the full statement (145 words)
The UniCel® DxH 800 Analyzer is a quantitative multi-parameter, automated hematology analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories.
The UniCel® DxH 800 Analyzer identifies and enumerates the parameters indicated below on the following sample types:
Whole Blood (venous and capillary) - WBC, RBC, HGB, HCT, MCV, MCH, MCHC, RDW, RDW-SD, PLT, MPV, NE%, NE#, LY%, LY#, MO%, MO#, EO%, EO#, BA%, BA#, NRBC%, NRBC#, RET%, RET#, MRV, IRF
Pre-Diluted Whole Blood (venous and capillary) - WBC, RBC, HGB, HCT, MCV, MCH, MCHC, RDW, RDW-SD, PLT, MPV
Body Fluids (cerebrospinal, serous and synovial) - TNC and RBC
The DxH Slidemaker Stainer is a fully automated slide preparation and staining device that aspirates a whole-blood sample, smears a blood film on a clean microscope slide, and delivers a variety of fixatives, stains, buffers, and rinse solutions to that blood smear.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K140911 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140911: Unicel DXH 800 Coulter Cellular Analysis System/ Unicel DXH Slidemaker Stainer Coulter Cellular Analysis System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140911
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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