# K972354: Abbott Cell-Dyn 3200 System

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Laboratories
- Decided: Sep 16, 1997 after 84 days
- Product code: GKZ (Counter, Differential Cell)
- Device class: 2
- Regulation: 21 CFR 864.5220
- Recalls of this device: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K823355 (1982). 4 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K955715: Cell Dyn 3500 Multi-Parameter Automated Hematology Analyzer (Modification), Abbott Laboratories (1996) Summary page 1.
- K930148: Technicon H* 3 RTX System (in-Vitro Diag. System), Heraeus Kulzer, Inc. (1993) Summary page 1.
- (no number) CELL-DYN 4000 System: named in the summary without a submission number

## Most influential descendants
- K980614: Abbott Cell-Dyn 3000 Series Hematology Systems (1998), 1 descendant of its own
- K061667: Cell-Dyn Ruby System (2006), 0 descendants of its own

## Recalls of this device
- Mar 15, 2011 · Not classified · Z-2018-2011: 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: 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: 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: The use of the device assemblies has been extended to a 6 month useful life.
- Mar 27, 2009 · Not classified · Z-1702-2011: 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: 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 unacceptabl

## Indications for use
The CELL-DYN® 3200 System is a fully automated hematology analyzer intended for in-vitro diagnostic use in the clinical laboratory.

Source page: https://510kreport.com/device/K972354
Methodology: https://510kreport.com/methodology