510(k) · Cleared
Recalled · 2011Abbott Cell-Dyn 3200 System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Abbott Laboratories · GKZ Counter, Differential Cell
Cleared on Sep 16, 1997 as substantially equivalent to K955715 (Abbott Laboratories, 1996) and 1 other predicate after an 84-day review. Its family tree reaches back 2 generations to 1982. 2 later devices descend from it. It has been recalled 6 times.
- Decided
- Sep 16, 1997
- Review
- 84 days
- Class
- Class II
- Product code
- GKZ
- Recalls
- 6
- Predicates
- 2
Its longest line of descent runs back 2 generations to K823355 (1982). 4 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK823355 Coulter-Counter #S Plus IV & Lyse S +DCoulter Electronics, Inc. · 1982
- 1 generation backK955715 Cell Dyn 3500 Multi-Parameter Automated Hematology Analyzer…Abbott Laboratories · 1996 · Recalled
- This deviceK972354 Abbott Cell-Dyn 3200 SystemAbbott Laboratories · 1997
- Descendant · cites it directly · 1 of its ownK980614 Abbott Cell-Dyn 3000 Series Hematology SystemsAbbott Laboratories · 1998 · Recalled
- Descendant · cites it directly · 0 of its ownK061667 Cell-Dyn Ruby SystemAbbott Laboratories · 2006 · Recalled
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K823355 | Coulter-Counter #S Plus IV & Lyse S +D | Coulter Electronics, Inc. | 1982 | — |
| −1 | K955715 | Cell Dyn 3500 Multi-Parameter Automated Hematology Analyzer (Modification) | Abbott Laboratories | 1996 | 1 |
| 0 (this device) | K972354 | Abbott Cell-Dyn 3200 System | Abbott Laboratories | 1997 | — |
| +1 | K980614 | Abbott Cell-Dyn 3000 Series Hematology Systems | Abbott Laboratories | 1998 | 5 |
| +1 | K061667 | Cell-Dyn Ruby System | Abbott Laboratories | 2006 | 12 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1993 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2006 | 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? (3)
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 |
|---|---|---|---|
| * | K955715 | Cell Dyn 3500 Multi-Parameter Automated Hematology Analyzer (Modification)Summary page 1…ermination. Substantial equivalence is demonstrated between the CELL-DYN® 3200 System and the Abbott the CELL-DYN® 3500R Multi-Parameter Automated Hematology Analyzer, #K955715 System for the White Blood Cell (WBC), Red Blood Cell (RBC), Hemoglobin concentration (HGB), Platelet count (PLT), WBC differenti… | 1996 |
| * | K930148 | Technicon H* 3 RTX System (in-Vitro Diag. System)Summary page 1…, Red Cell Distribution Width (RDW), and Mean Platelet Volume (MPV). Substantial equivalence is demonstrated between the CELL-DYN® 3200 System and the Technicon H'3 RTC #K930148 for the hemogram and white cell (WBC) differential parameters. Additional data was collected to demonstrate the comparison of the… | 1993 |
| * | — | CELL-DYN 4000 System Named without a submission number |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 15, 2011 | Not classified | Z-2018-2011 | Pending | The Nylon Washer has an outer diameter which is undersized resulting in the inability to generate patient results. |
| Mar 15, 2011 | Not classified | Z-2017-2011 | Pending | The Nylon Washer has an outer diameter which is undersized resulting in the inability to generate patient results. |
| Apr 16, 2010 | Not classified | Z-2350-2010 | Nonconforming Material/Component | Epoxy holding the two parts of the waste reservoir together fails, potentially resulting in biohazardous fluid leaks. |
| Nov 30, 2009 | Not classified | Z-1698-2011 | Other | The use of the device assemblies has been extended to a 6 month useful life. |
| Mar 27, 2009 | Not classified | Z-1702-2011 | Component design/selection | FIRE HAZARD-- Some power supply modules may have incorrect fuses installed, which may result in fires and smoking. |
| Sep 29, 2004 | Not classified | Z-0706-2007 | Other | Elevated platelet background count results-some products may show a higher than expected platelet background count when used on the CELL-DYN 3200 System and report patient results that are unacceptable-out-of-range |
The 5 latest of 6 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 15 years and passes through 2 companies; a new generation was cleared every 13.8 years on median.
- 2 of the 4 ancestors have a recall of any class.
- Of its descendants, K980614 (Abbott Laboratories, 1998) has gone furthest, with 1 descendant 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 | — |
What is it indicated for?
The CELL-DYN® 3200 System is a fully automated hematology analyzer intended for in-vitro diagnostic use in the clinical laboratory.
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/K972354 · printed Nov 6, 2026
Cite this page
510(k) Report. “K972354: Abbott Cell-Dyn 3200 System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K972354
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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