510(k) · Cleared
Recalled · Class II · 2017Coulter LH 750 Hematology Analyzer, Model 6605632
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 Jul 9, 2001 after a 68-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 12 later devices descend from it. It has been recalled 15 times.
- Decided
- Jul 9, 2001
- Review
- 68 days
- Class
- Class II
- Product code
- GKZ
- Recalls
- 15
- Predicates
- 0
12 later devices descend from it, 8 citing it directly.
- This deviceK011342 Coulter LH 750 Hematology Analyzer, Model 6605632Beckman Coulter, Inc. · 2001
- Descendant · cites it directly · 2 of its ownK032342 Coulter LH 750 Hematology AnalyzerBeckman Coulter, Inc. · 2003 · Recalled
- Descendant · cites it directly · 2 of its ownK022161 Modification to Coulter LH 750 Hematology Analyzer, Model 6605632Beckman Coulter, Inc. · 2002 · Recalled
- Descendant · cites it directly · 1 of its ownK061616 Coulter LH 780 Hematology AnalyzerBeckman Coulter, Inc. · 2006 · Recalled
- Descendant · cites it directly · 1 of its ownK041882 Flowcare SystemPointcare Technologies, Inc. · 2004
- Descendant · cites it directly · 1 of its ownK032000 Coulter LH 500 Hematology AnalyzerBeckman Coulter, Inc. · 2003 · Recalled
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K032342Coulter LH 750 Hematology AnalyzerBeckman Coulter, Inc. · 2003 · cites it directly2descendants
- K022161Modification to Coulter LH 750 Hematology Analyzer, Model 6605632Beckman Coulter, Inc. · 2002 · cites it directly2descendants
- K061616Coulter LH 780 Hematology AnalyzerBeckman Coulter, Inc. · 2006 · cites it directly1descendant
- K041882Flowcare SystemPointcare Technologies, Inc. · 2004 · cites it directly1descendant
- K032000Coulter LH 500 Hematology AnalyzerBeckman Coulter, Inc. · 2003 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K011342 | Coulter LH 750 Hematology Analyzer, Model 6605632 | Beckman Coulter, Inc. | 2001 | — |
| +1 | K032342 | Coulter LH 750 Hematology Analyzer | Beckman Coulter, Inc. | 2003 | 1 |
| +1 | K022161 | Modification to Coulter LH 750 Hematology Analyzer, Model 6605632 | Beckman Coulter, Inc. | 2002 | 2 |
| +1 | K061616 | Coulter LH 780 Hematology Analyzer | Beckman Coulter, Inc. | 2006 | 7 |
| +1 | K041882 | Flowcare System | Pointcare Technologies, Inc. | 2004 | — |
| +1 | K032000 | Coulter LH 500 Hematology Analyzer | Beckman Coulter, Inc. | 2003 | 9 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 3 | 0 |
| 2004 | 3 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2008 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (12)
See all 128 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K032342 | Coulter LH 750 Hematology Analyzer | 2003 | 2 |
| K022161 | Modification to Coulter LH 750 Hematology Analyzer, Model 6605632 | 2002 | 2 |
| K061616 | Coulter LH 780 Hematology Analyzer | 2006 | 1 |
| K041882 | Flowcare System | 2004 | 1 |
| K032000 | Coulter LH 500 Hematology Analyzer | 2003 | 1 |
| K081930 | Unicel DXH 800 Coulter Cellular Analysis System | 2008 | 0 |
| K061574 | Coulter LH 750 Hematology Analyzer, Model 6605632 | 2006 | 0 |
| K052905 | Modification to Coulter LH 750 Hematology Analyzer | 2005 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 26, 2017 | Class II | Z-3113-2017 | Labeling Change Control | Beckman Coulter has determined that additional clarification for the Blast Suspect messages is necessary. In rare situations, the LH 750, LH 780, LH 500 and HmX Analyzers may not flag or detect blasts in some blood samples. |
| Jul 22, 2015 | Class II | Z-2481-2015 | Nonconforming Material/Component | Beckman Coulter is recalling the LH 750 and LH780 Hematology Systems because the use of the diluent lots may eventually result in a compromised Hgb cuvette. |
| Jul 22, 2015 | Class II | Z-2480-2015 | Nonconforming Material/Component | Beckman Coulter is recalling the LH 750 and LH780 Hematology Systems because the use of the diluent lots may eventually result in a compromised Hgb cuvette. |
| Nov 8, 2013 | Class II | Z-0470-2014 | Under Investigation by firm | Beckman Coulter is recalling the LH 750 and LH 780 Hematology Systems because the optical degradation may potentially cause a delay in reporting results for nucleated red blood cells (nRBC), white blood cell differential and/or… |
| Sep 24, 2013 | Class II | Z-0113-2014 | Component change control | The check valves may fail on the Coulter LH 750 Hematology Analyzer (PN 6605632 and A85570) and Coulter LH 780 Hematology Analyzer (PN 723585 and A90728). A failure may result in an air or liquid leak at the connection to the Vacuum… |
| Dec 1, 2011 | Not classified | Z-1242-2012 | Software design | The recall was initiated because Beckman Coulter has confirmed that the Auto Stop and Auto Transmit features for Quality Control become disabled after scanning assay values from Coulter 5C and Retic-C Cell Controls assay sheets using the… |
| Jan 31, 2011 | Not classified | Z-1953-2011 | Software design | This recall was initiated because Beckman Coulter identified a problem with some date fields that are transmitted to the Laboratory Information System (LIS). Starting Jan 1, 2011, the date fields will transmit as a blank field to the LIS… |
| Apr 18, 2007 | Not classified | Z-0312-2008 | Software design | Patient Mis-identification can occur: 1)- When a positive identifier (Sample ID or Cassette/Position) is manually edited to a positive identifier that is already in the To Do list. The workstation will accept the entry and no error… |
| Sep 12, 2006 | Not classified | Z-0566-2007 | Other | There is a potential for erroneous yet credible results for Body Fluids on the LH700 series hematology analyzers when a cassette label fails to read and the subsequent sample is cycled in Body Fluid mode. |
| Dec 15, 2005 | Not classified | Z-0474-06 | Other | There is a risk of sample misidentification when processing samples in the Manual aspiration mode. |
| Mar 31, 2004 | Not classified | Z-0905-04 | Other | If a customer enters a dilution factor for Sample B prior to the results from Sample A being transfered to the workstation, the predilute multiplication factor will be applied erroneously to the Sample A's results once they are received… |
| Jan 10, 2003 | Not classified | Z-0541-03 | Other | Biohazard situation exists for users. |
| Dec 27, 2002 | Not classified | Z-0669-03 | Other | Incorrect Hemoglobin result can be reported with software version 2A and higher. |
| Dec 10, 2002 | Not classified | Z-0571-03 | Other | Device design allows for cross contamination issue to occur, possibly affecting assays and results reports. |
| Nov 8, 2002 | Not classified | Z-0415-03 | Other | Software vote out logic changed. Erroneous white blood cell counts. |
The 5 latest of 15 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K032342 (Beckman Coulter, Inc., 2003) has gone furthest, with 2 descendants 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.
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 | — |
https://510kreport.com/device/K011342 · printed Nov 6, 2026
Cite this page
510(k) Report. “K011342: Coulter LH 750 Hematology Analyzer, Model 6605632.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K011342
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026