# K980614: Abbott Cell-Dyn 3000 Series Hematology Systems

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Laboratories
- Decided: Apr 24, 1998 after 81 days
- Product code: GKZ (Counter, Differential Cell)
- Device class: 2
- Regulation: 21 CFR 864.5220
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K823355 (1982). 9 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K972354: Abbott Cell-Dyn 3200 System, Abbott Laboratories (1997) Summary page 1.
- K960427: Abbott Cell-Dyn 3500R System, Sequoia Turner Corp. (1996) Summary page 1.
- K955673: Cell Dyn 3000 Multi-Parameter Automated Hematology Analyzer (Modification), Abbott Laboratories (1996) Summary page 1.

## Most influential descendants
- K061667: Cell-Dyn Ruby System (2006), 0 descendants of its own

## Recalls of this device
- 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-1902-2011: Expanded Recall to include these additional products: FIRE HAZARD-- Some power supply modules may have incorrect fuses installed, which may result in fires and smoking.
- May 11, 2007 · Not classified · Z-1199-2007: The product failed electrostatic discharge testing, which could result in product failure.
- May 11, 2007 · Not classified · Z-1200-2007: The product failed electrostatic discharge testing, which could result in product failure.
- May 11, 2007 · Not classified · Z-1198-2007: The product failed electrostatic discharge testing, which could result in product failure.

## Indications for use
The Cell-Dyn® 3000 Series instruments process human whole blood specimens to provide a hemogram with automated differential..

Source page: https://510kreport.com/device/K980614
Methodology: https://510kreport.com/methodology