# K961439: Abbott Cell-Dyn 4000 System

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Diagnostics
- Decided: Oct 18, 1996 after 186 days
- Product code: GKZ (Counter, Differential Cell)
- Device class: 2
- Regulation: 21 CFR 864.5220
- Recalls of this device: 7 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K872166 (1987). 2 ancestors in all.
7 later devices descend from it; 5 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K951496: Cell-Dyn 3500 Multi-Parameter Automated Hematology Analyzer, Abbott Laboratories (1995) Summary page 1.
- K872166: Facscan Flow Cytometer - Reticcount Reti. Enu. Kit, Bd Becton Dickinson Vacutainer Systems Preanalytic (1987) Summary page 1.

## Most influential descendants
- K022200: Pentra 120/Pentra 120 Retic Options SPS, Model Pentra 120 (2002), 2 descendants of its own
- K050719: Abx Pentra DX 120: Option SPS Evolution (2005), 1 descendant of its own
- K024002: Pentra 80 (2003), 1 descendant of its own
- K012934: Cell-Dyn 3200 System with Absolute and Percent Reticulocyte (2001), 1 descendant of its own
- K151133: Pentra XLR (2015), 0 descendants of its own

## Recalls of this device
- Dec 29, 2009 · Not classified · Z-1623-2011: A component used in assembly is out of specification, resulting in failure to retract, eject specimens, exposure below the safety zone, piercing of specimen tubes, or error message to display.
- Dec 19, 2007 · Not classified · Z-1103-2008: Microbial Contamination: The WBC (White Blood Cell) Reagent Part A was confirmed positive for Pseudomonas contamination.
- Dec 22, 2006 · Not classified · Z-0565-2007: Results for tests of RBC, MCV, RDW, MPV and PLT may be falsely elevated or falsely decreased when the Cell Dyn Diluent/Sheath reagent is used with Cell-Dyn 4000, Ruby and Sapphire systems.
- Apr 17, 2006 · Not classified · Z-0708-2007: High platelet background count when using the CELL-DYN 4000 System and/or CELL-DYN Sapphire System; with patient results unacceptable -out-of-range.
- May 12, 2004 · Not classified · Z-0639-2007: Incorrect Test Results-test results may show a higher than expected platelet background count when used on the CELL-DYN 4000 System and report patient results that are unacceptable (out-of-range).
- Feb 24, 2004 · Not classified · Z-0640-2007: Incorrect Test Results-product may show a higher than expected platelet background count when used on the CELL-DYN 4000 System and report patient results that are unacceptable (out-of-range).
- Oct 16, 2002 · Not classified · Z-0648-03: Product elicits fluorescent signal interference due to contamination.

## Indications for use
The CELL-DYN® 4000 System is a fully automated hematology analyzer intended for in-vitro diagnostic use in the clinical hematology laboratory of a hospital, medical clinic, or reference laboratory.

Source page: https://510kreport.com/device/K961439
Methodology: https://510kreport.com/methodology