# K991605: Cell-Dyn 3500 System with Immature Reticulocyte Fraction (Irf), Cell-Dyn 3700 System with Immature Reticulocyte Fraction

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Laboratories
- Decided: Jul 9, 1999 after 60 days
- Product code: GKZ (Counter, Differential Cell)
- Device class: 2
- Regulation: 21 CFR 864.5220
- Recalls of this device: 9 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K971152 (1997). 1 ancestor in all.
3 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K971152: Abbott Cell-Dyn 4000 Immature Reticulocyte Fraction (Irf), Abbott Laboratories (1997) Summary page 1.

## Most influential descendants
- K110381: Cell-Dyn Emerald 22 System (2011), 1 descendant of its own
- K190294: CELL-DYN Emerald 22 AL System (2019), 0 descendants of its own
- K112755: Abacus 5 (2012), 0 descendants of its own

## Recalls of this device
- Mar 15, 2011 · Not classified · Z-2020-2011: The Nylon Washer has an outer diameter which is undersized resulting in the inability to generate patient results.
- Mar 15, 2011 · Not classified · Z-2015-2011: The Nylon Washer has an outer diameter which is undersized resulting in the inability to generate patient results.
- Mar 15, 2011 · Not classified · Z-2016-2011: The Nylon Washer has an outer diameter which is undersized resulting in the inability to generate patient results.
- Mar 15, 2011 · Not classified · Z-2014-2011: The Nylon Washer has an outer diameter which is undersized resulting in the inability to generate patient results.
- Apr 16, 2010 · Not classified · Z-2351-2010: Epoxy holding the two parts of the waste reservoir together fails, potentially resulting in biohazardous fluid leaks.
- Mar 27, 2009 · Not classified · Z-1701-2011: FIRE HAZARD-- Some power supply modules may have incorrect fuses installed, which may result in fires and smoking.
- Mar 27, 2009 · Not classified · Z-1703-2011: 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.

## Indications for use
The CELL-DYN 3500 and the CELL-DYN 3700 Systems are automated, multi-parameter hematology analyzers intended to classify the following formed elements of EDTA anticoagulated blood: WBC -- White Blood Cell or Leukocyte Count NEU -- Neutrophil Absolute Count %N -- Neutrophil Percent LYM -- Lymphocyte Absolute Count %L -- Lymphocyte Percent MONO -- Monocyte Absolute Count %M -- Monocyte Percent EOS -- Eosinophil Absolute Count %E -- Eosinophil Percent BASO -- Basophil Absolute Count %B -- Basophil Percent PLT -- Platelet Count MPYV -- Mean Platelet Volume RBC -- Red Blood Cell or Erythrocyte Count HCT - Hematocrit MCYV -- Mean Corpuscular Volume RDW -- Red Cell Distribution Width HGB -- Hemoglobin Concentration MCH -- Mean Corpuscular Hemoglobin MCHC -- Mean Corpuscular Hemoglobin Concentration RETC -- Reticulocyte Concentration % RETC -- Reticulocyte Concentration IRF -- Immature Reticulocyte Fraction *PDW -- Platelet Distribution Width *PCT -- Plateletcrit * These parameters are provided for laboratory use only and are not reportable in the US.

Source page: https://510kreport.com/device/K991605
Methodology: https://510kreport.com/methodology