510(k) · Cleared
Recalled · Class II · 2017Coulter HMX Analyzer, Model 6605523, Coulter HMX with Autoloader, Model 6605526
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 Apr 13, 2001 after a 30-day review. FDA has not posted a summary or statement for it, so its predicates are not known. It has been recalled 6 times.
- Decided
- Apr 13, 2001
- Review
- 30 days
- Class
- Class II
- Product code
- GKZ
- Recalls
- 6
- Predicates
- 0
FDA has not posted a summary or statement for it, so its predicates are not known.
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?
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 |
|---|---|---|---|---|
| Jun 26, 2017 | Class II | Z-3114-2017 | 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. |
| Oct 13, 2011 | Not classified | Z-0600-2012 | Nonconforming Material/Component | The recall was initiated because Beckman has identified a problem with Integrated Circuit chips used in different boards throughout the analyzer. |
| Oct 13, 2011 | Not classified | Z-0601-2012 | 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-2044-2011 | 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. |
| Mar 2, 2011 | Not classified | Z-2043-2011 | 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. |
| Dec 14, 2010 | Not classified | Z-1730-2011 | Other | The recall was initiated because Beckman Coulter has confirmed the Coulter MAXM, MAXM AL, HmX and HmX AL Analyzers omit the tilde (~) character when the tilde is used as part of the Sample 10 within a barcode label scanned by the primary… |
The 5 latest of 6 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
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/K010765 · printed Nov 6, 2026
Cite this page
510(k) Report. “K010765: Coulter HMX Analyzer, Model 6605523, Coulter HMX with Autoloader, Model 6605526.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K010765
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026