510(k) · Cleared
Recalled · Class II · 2017Unicel DXH 800 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 Dec 19, 2008 as substantially equivalent to K011342 (Beckman Coulter, Inc., 2001) and 1 other predicate after a 165-day review. Its family tree reaches back 4 generations to 1991. It has been recalled 29 times.
- Decided
- Dec 19, 2008
- Review
- 165 days
- Class
- Class II
- Product code
- GKZ
- Recalls
- 29
- Predicates
- 2
Its longest line of descent runs back 4 generations to K912494 (1991). 8 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK912494 Sysmex (TM) R-3000 Automated Reticulocyte AnalyzerToa Medical Electronics USA, Inc. · 1991
- 3 generations backK964375 Sysmex SE/Ram-1Sysmex Corp. · 1997
- 2 generations backK992875 Sysmex XE-2100, Automatated Hematology AnalyzerSysmex Corp. · 1999 · Recalled
- 1 generation backK061616 Coulter LH 780 Hematology AnalyzerBeckman Coulter, Inc. · 2006 · Recalled
- This deviceK081930 Unicel DXH 800 Coulter Cellular Analysis SystemBeckman Coulter, Inc. · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K912494 | Sysmex (TM) R-3000 Automated Reticulocyte Analyzer | Toa Medical Electronics USA, Inc. | 1991 | — |
| −3 | K964375 | Sysmex SE/Ram-1 | Sysmex Corp. | 1997 | — |
| −2 | K992875 | Sysmex XE-2100, Automatated Hematology Analyzer | Sysmex Corp. | 1999 | 1 |
| −1 | K061616 | Coulter LH 780 Hematology Analyzer | Beckman Coulter, Inc. | 2006 | 7 |
| 0 (this device) | K081930 | Unicel DXH 800 Coulter Cellular Analysis System | Beckman Coulter, Inc. | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 2001 | 1 | 0 |
| 2003 | 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.
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? (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 |
|---|---|---|---|
| * | K011342 | Coulter LH 750 Hematology Analyzer, Model 6605632Summary page 1…Candidate Predicates Manufacturer Number UniCel®)Dxli 800 COULTER® LH 750 Beckman Coulter, Inc. K01 1342 Coulter®~ Cellular Hematology Analyzer Analysis System COULTER® LH 780… | 2001 |
| * | K061616 | Coulter LH 780 Hematology AnalyzerSummary page 1…1 1342 Coulter®~ Cellular Hematology Analyzer Analysis System COULTER® LH 780 Beckman Coulter, Inc. K061616 Hematology Analyzer UniCelo DxH 800 Analyzer… | 2006 |
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 |
|---|---|---|---|---|
| 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… |
| 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… |
| Apr 13, 2015 | Class II | Z-1616-2015 | Nonconforming Material/Component | Beckman Coulter has received an increased number of complaints related to Hemoglobin (HGB) on UniCel DxH 800 and DxH 600 Coulter Cellular Analysis Systems. The use of the DxH Diluent lots listed in the recall notice may eventually result… |
| Nov 8, 2013 | Class II | Z-1828-2014 | Under Investigation by firm | Beckman Coulter is recalling the UniCel DxH800 and UniCel DxH600 Coulter Analysis Systems because the optical degradation may potentially cause a delay in reporting results for nucleated red blood cells (nRBC), automated white blood cell… |
| Nov 8, 2013 | Class II | Z-1829-2014 | Under Investigation by firm | Beckman Coulter is recalling the UniCel DxH800 and UniCel DxH600 Coulter Analysis Systems because the optical degradation may potentially cause a delay in reporting results for nucleated red blood cells (nRBC), automated white blood cell… |
| Sep 24, 2013 | Class II | Z-0147-2014 | Under Investigation by firm | Beckman Coulter is initiating a recall for UniCel DxH 800 Coulter Cellular Analysis System (PN 629029) and UniCel DxH 600 Coulter Cellular Analysis System (PN B23858) because the company's internal investigation indicates that specific… |
| Apr 3, 2012 | Class II | Z-0021-2013 | Device Design | Beckman Coulter is recalling the UniCel DxH 800 Coulter Cellular Analysis System because the NRBC, Differential or Reticulocyte mix chamber drain ports may become plugged by rubber pieces from specimen tube caps, and result in biohazard… |
| May 9, 2011 | Not classified | Z-3125-2011 | Pending | The recall was initiated because Beckman Coulter has confirmed that the probe wash collar tubing may become stretched or trapped at the Sample Aspiration Module (SAM) during routine use of single-tube presentation station. When the… |
| Apr 14, 2011 | Not classified | Z-2227-2011 | Software design | The recall was initiated because Beckman Coulter has confirmed the auto prune will not remove patient results if the patient record includes demographics where the results are less than 30 days old. |
| Feb 11, 2011 | Not classified | Z-2172-2011 | Pending | The recall was initiated because: Specimen tubes may fall out of a Type A cassette (PN A53551, kit of 20) when the analyzer inverts the cassette in the mixing station, or when an operator manually inverts a cassette The impact: - Specimen… |
| Feb 11, 2011 | Not classified | Z-2145-2011 | Other | The recall was initiated because the DxH 800 may fail to meet the carryover specification for the WBC Differential (DIFF) when the WBC is greater than 70 X 10 to the 3rd power cells/micro L (70 X 10 to the 9th power cells/L). Beckman… |
| Feb 11, 2011 | Not classified | Z-2157-2011 | Pending | The recall was initiated because: The handheld barcode scanner does not read barcode labels using NW 7 symbology. Impact: Specimens with NW7 labels cannot be read by the handheld scanner. |
| Feb 11, 2011 | Not classified | Z-2148-2011 | Other | The recall was initiated because: The DxH 800 may fail to meet the carryover specification for NRBC% when the WBC is greater than 50 X 10 to the 3rd power cells/micro L (50 X 10 to the 9th power cells/L) Beckman Coulter indicated the… |
| Oct 20, 2010 | Not classified | Z-1978-2011 | Other | There is a possibility that a specimen could be diluted if a user requests Diluent Dispense while specimens are being automatically processed in cassette presentation. The dilution may cause erroneous results. IMPACT: Erroneous results… |
| Oct 20, 2010 | Not classified | Z-1980-2011 | Other | Sharp edges on drawer slides within the DxH800 Floor Stand (Cabinet) may expose operators to physical injury while replacing reagents and waste containers. IMPACT: There is potential for exposure to blood borne pathogens such as HIV, HBV… |
| Oct 20, 2010 | Not classified | Z-2128-2011 | Other | Body Fluids results may be incorrectly interpreted by the Laboratory Information System (LIS). Body Fluid results ~ 1,000 celis/uL are reported using the US numeric separators to demark thousandths places (comma, ",") and partial units… |
| Oct 20, 2010 | Not classified | Z-2121-2011 | Other | RETIC results may be invalid when the instrument user interface allows reflex processing of a pre-diluted specimen in the RETIC test panel. Beckman Coulter has validated pre-diluted specimen processing in CBC panels. RETIC test panel… |
| Oct 20, 2010 | Not classified | Z-1977-2011 | Other | There is a possibility that a specimen could be diluted if a user requests Diluent Dispense while specimens are being automatically processed in cassette presentation. The dilution may cause erroneous results. IMPACT: Erroneous results… |
| Oct 20, 2010 | Not classified | Z-2114-2011 | Other | For Panels containing CBC: The RBC and HCT are improperly corrected and not flagged when there is a WBC Pump Failure and the WBC ~ 140x103/uL. For Body Fluid Panels: The RBC is improperly corrected and not flagged when there is a WBC Pump… |
| Mar 2, 2010 | Not classified | Z-1656-2010 | Software design | Issue 1: The Diagnostic procedure, Simulate-CDNR Cycle, is not functioning properly. Impact: There is a potential for inadequate sample preparation of samples following the use of this Diagnostic function impacting WBC, Differential… |
| Feb 12, 2010 | Not classified | Z-2338-2010 | Software design | The recall was initiated after Beckman Coulter identified four (4) issues with the COULTER LH 500 Series System and the Unicel DxH 800 Coulter Cellular Analysis System: Issue 1: There is a potential for misidentification to occur when the… |
| Feb 4, 2010 | Not classified | Z-1658-2010 | Software design | Issue 1: The system will substitute or omit the characters # @ 1 \ ] ' ( I ) - when the instrument is configured in a language other than English, Chinese or Japanese. Example: Using the character @, a substitution in the string '123@456'… |
| Dec 8, 2009 | Not classified | Z-1680-2010 | Software design | The Corrective Action was initiated after Beckman Coulter confirmed three issues related to host transmissions with the UniCel DxH 800. This information only affects instruments interfaced to a host system. |
| Jul 28, 2009 | Not classified | Z-1905-2010 | Other | The recall was initiated after Beckman Coulter confirmed an issue with the UniCel DxH 800 during in-house testing. It was determined that there is a potential for a false increase in platelet results, due to micro-bubbles. This situation… |
The 5 latest of 29 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 17 years and passes through 3 companies; a new generation was cleared every 5.5 years on median.
- 4 of the 8 ancestors have a recall of any class.
- 7 other devices also cite its predicate K011342.
How does its category compare?
All GKZ devicesGKZ Counter, Differential Cell: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · GKZ
4in 2025
2007high 6 (2007) · low 0 (2021)2026
2026 to Oct 25, outlined.
Median 510(k) review, days · GKZ
108in 2025
2007high 638 (2022) · low 99 (2008)2026
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GKZ
1in 2025
2007high 37 (2007) · low 0 (2014)2026
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · GKZ
77in 2025
2007high 3,338 (2016) · low 77 (2025)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, automated hematology analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories. The UniCel® DxH 800 Analyzer provides:
· a Complete Blood Count (CBC), Leukocyte 5 Part Differential (Diff), Reticulocyte (Retic) and Nucleated Red Blood Cell (NRBC) on whole blood
· a Total Nucleated Count (TNC) and Red Cell Count (RBC) on Body Fluids (cerebrospinal, serous and synovial) (BF)
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/K081930 · printed Nov 5, 2026
Cite this page
510(k) Report. “K081930: Unicel DXH 800 Coulter Cellular Analysis System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K081930
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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