# K140911: Unicel DXH 800 Coulter Cellular Analysis System/ Unicel DXH Slidemaker Stainer Coulter Cellular Analysis System

- Pathway: 510(k) (Abbreviated)
- Applicant: Beckman Coulter, Inc.
- Decided: Sep 5, 2014 after 149 days
- Product code: GKZ (Counter, Differential Cell)
- Device class: 2
- Regulation: 21 CFR 864.5220
- Recalls of this device: 17 (3 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K120771 (2013). 1 ancestor in all.
6 later devices descend from it; 5 cite it directly.
1 of 8 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120771: Unicel DXH 800 Coulter Cellular Analysis System, Beckman Coulter, Inc. (2013) Summary page 7.
- (no number) Manually prepared blood films per the manual wedge-pull film technique as described in CLSI H20-A2, Reference Leukocyte (WBC) Differential Count (Proportional) and Evaluation of Instrumental Methods; Approved Standard: named in the summary without a submission number

## Most influential descendants
- K193124: Unicel DxH 800 Coulter Cellular Analysis System (2020), 1 descendant of its own
- K162414: UniCel DxH SlideMaker Stainer Coulter Cellular Analysis System (2016), 1 descendant of its own
- K240252: UniCel DxH 900 Coulter Cellular Analysis System; UniCel DxH Slidemaker Stainer II Coulter Cellular Analysis System; UniCel DxH 690T Coulter Cellular Analysis System (2024), 0 descendants of its own
- K230878: QScout Lab; QScout RLD (2023), 0 descendants of its own
- K181475: DxH 520 Hematology Instrument (2019), 0 descendants of its own

## Recalls of this device
- Oct 7, 2019 · Class II · Z-0516-2020: 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 cou
- Jul 30, 2018 · Class I · Z-1383-2019: 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: 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: 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: 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: 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: 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: 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: 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 
- Apr 24, 2017 · Class II · Z-2157-2017: 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 
- Dec 19, 2016 · Class II · Z-1013-2017: 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 fl
- Dec 19, 2016 · Class II · Z-1014-2017: 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 fl
- Aug 8, 2016 · Class II · Z-2732-2016: 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: 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 Stai
- Dec 1, 2015 · Class II · Z-0433-2016: 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 order
- Dec 1, 2015 · Class II · Z-0434-2016: 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 order
- Dec 1, 2015 · Class II · Z-0432-2016: 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 order

## Indications for use
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.

Source page: https://510kreport.com/device/K140911
Methodology: https://510kreport.com/methodology