510(k) · Cleared
Recalled · 2011Coulter LH 500 Hematology Analyzer
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 Aug 13, 2003 as substantially equivalent to K011342 (Beckman Coulter, Inc., 2001) after a 64-day review. Its family tree reaches back 1 generation to 2001. 1 later device descends from it. It has been recalled 9 times.
- Decided
- Aug 13, 2003
- Review
- 64 days
- Class
- Class II
- Product code
- GKZ
- Recalls
- 9
- Predicates
- 1
Its longest line of descent runs back 1 generation to K011342 (2001). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK011342 Coulter LH 750 Hematology Analyzer, Model 6605632Beckman Coulter, Inc. · 2001 · Recalled
- This deviceK032000 Coulter LH 500 Hematology AnalyzerBeckman Coulter, Inc. · 2003
- Descendant · cites it directly · 0 of its ownK042724 Modification to Coulter LH 500 Hematology AnalyzerBeckman Coulter, Inc. · 2004
Most influential descendants
Showing 1 of 1 · See all- K042724Modification to Coulter LH 500 Hematology AnalyzerBeckman Coulter, Inc. · 2004 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K011342 | Coulter LH 750 Hematology Analyzer, Model 6605632 | Beckman Coulter, Inc. | 2001 | 15 |
| 0 (this device) | K032000 | Coulter LH 500 Hematology Analyzer | Beckman Coulter, Inc. | 2003 | — |
| +1 | K042724 | Modification to Coulter LH 500 Hematology Analyzer | Beckman Coulter, Inc. | 2004 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 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? (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 |
|---|---|---|---|
| * | K011342 | Coulter LH 750 Hematology Analyzer, Model 6605632 | 2001 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K042724 | Modification to Coulter LH 500 Hematology Analyzer | 2004 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 1, 2011 | Not classified | Z-1243-2012 | 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… |
| Oct 13, 2011 | Not classified | Z-0599-2012 | Nonconforming Material/Component | The recall was initiated because Beckman has identified a problem with Integrated Circuit chips used in different boards throughout the analyzer. |
| Mar 2, 2011 | Not classified | Z-2042-2011 | Other | The recall was initiated because Beckman Coulter has identified a problem with Integrated Circuit Chips used in different boards throughout the Beckman Coulter LH500/HmX/HmX Autoloader Hematology analyzer. |
| Jan 31, 2011 | Not classified | Z-1955-2011 | 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… |
| Feb 12, 2010 | Not classified | Z-2337-2010 | 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-1657-2010 | Software design | Issue 1: The system will substitute or omit the characters # @ [\] ' {I) when the system is configured in a language other than English or Chinese. Example: Using the character @, a substitution in the string '123@456' would result in… |
| Apr 18, 2007 | Not classified | Z-0314-2008 | 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… |
| Apr 17, 2006 | Not classified | Z-1245-06 | Other | Beckman has confirmed that erroneous results could be reported when the workstation database crashes. |
| Aug 12, 2004 | Not classified | Z-1433-04 | Other | Beckman Coulter has confirmed an issue associated with the predilute mode of the COULTER LH 500 Hematology Analyzer. The workstation may display, transmit, and / or print an erroneous result or an incorrect dilution factor with a… |
The 5 latest of 9 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
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 | — |
What is it indicated for?
The COULTERB LH 500 is a quantitative, automated hematology analyzer For In Vitro Diagnostic Use in clinical laboratories. The LH 500 System provides automated complete blood count and leukocyte differential. The product also provides semi-automated reticulocyte analysis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032000 · printed Nov 6, 2026
Cite this page
510(k) Report. “K032000: Coulter LH 500 Hematology Analyzer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032000
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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