# K061667: Cell-Dyn Ruby System

- Pathway: 510(k) (Special)
- Applicant: Abbott Laboratories
- Decided: Jul 10, 2006 after 26 days
- Product code: GKZ (Counter, Differential Cell)
- Device class: 2
- Regulation: 21 CFR 864.5220
- Recalls of this device: 12 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K823355 (1982). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 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.
- K980614: Abbott Cell-Dyn 3000 Series Hematology Systems, Abbott Laboratories (1998) Summary page 1.
- K012934: Cell-Dyn 3200 System with Absolute and Percent Reticulocyte, Abbott Laboratories (2001) Summary page 1.

## Recalls of this device
- Mar 18, 2025 · Class II · Z-1655-2025: When expired reagents are scanned or manually entered, the system will change the expiration date to current or future date without notifying user that an expired reagent is being used. Use of expired
- Mar 18, 2025 · Class II · Z-1653-2025: When expired reagents are scanned or manually entered, the system will change the expiration date to current or future date without notifying user that an expired reagent is being used. Use of expired
- Mar 18, 2025 · Class II · Z-1654-2025: When expired reagents are scanned or manually entered, the system will change the expiration date to current or future date without notifying user that an expired reagent is being used. Use of expired
- Mar 18, 2025 · Class II · Z-1656-2025: When expired reagents are scanned or manually entered, the system will change the expiration date to current or future date without notifying user that an expired reagent is being used. Use of expired
- Mar 18, 2025 · Class II · Z-1652-2025: When expired reagents are scanned or manually entered, the system will change the expiration date to current or future date without notifying user that an expired reagent is being used. Use of expired
- Oct 19, 2023 · Class II · Z-0604-2024: The devices contain a dry natural rubber (latex) subcomponent, which are not labeled as containing dry natural rubber(latex).
- Feb 13, 2017 · Class II · Z-1438-2017: The Pump Relay Printed Circuit Board Assembly (PCBA) used in the CELL-DYN Ruby instrument may prematurely fail and lead to instrument stoppage
- Mar 15, 2011 · Not classified · Z-2019-2011: The Nylon Washer has an outer diameter which is undersized resulting in the inability to generate patient results.
- Apr 16, 2010 · Not classified · Z-2352-2010: Epoxy holding the two parts of the waste reservoir together fails, potentially resulting in biohazardous fluid leaks.
- Feb 12, 2009 · Not classified · Z-1398-2009: Burn Risk-- when power is cycled to the instrument, there is a possibility that the Mixer Motor Assembly may reach 100 degrees Celsius (212 degrees Fahrenheit ). If the customer touches the motor, bur
- Nov 17, 2008 · Not classified · Z-1064-2009: Carryover failures in software revisions 1.0ML and 2.0ML result in elevated PLT background count.
- 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.

## Indications for use
The CELL-DYN Ruby System is designed to analyze EDTA-anticoagulated blood and report the following hematological parameters: White Blood Cell Parameters WBC - White Blood Cell Concentration NEU - Neutrophil Absolute Concentration %N - Neutrophil Percentage of WBC LYM - Lymphocyte Absolute Concentration %L - Lymphocyte Percentage of WBC MONO - Monocyte Absolute Concentration %M - Monocyte Percentage of WBC EOS - Eosinophil Absolute Concentration %E - Eosinophil Percentage of WBC BASO - Basophil Absolute Concentration %B - Basophil Percentage of WBC Red Blood Cell Parameters RBC - Red Blood Cell Concentration HCT - Hematocrit MCV - Mean Cell Volume RDW - Red Cell Distribution Width %R - Reticulocyte Percent RETC - Reticulocyte Absolute Concentration Hemoglobin Parameters HGB - Hemoglobin Concentration MCH - Mean Cell Hemoglobin MCHC - Mean Cell Hemoglobin Concentration Platelet Parameters PLT- Platelet Concentration MPV- Mean Platelet Volume

Source page: https://510kreport.com/device/K061667
Methodology: https://510kreport.com/methodology