# K081495: Cell-Dyn Emerald System

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Laboratories
- Decided: Feb 4, 2009 after 251 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: 2 generations back to K870233 (1987). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030513: Cell-Dyn 1800 System, Abbott Laboratories (2003) Summary page 1.

## Recalls of this device
- May 9, 2019 · Class II · Z-0173-2020: The diluent tubing used on the instrument appears cloudy or to have a powder/film on the inner and outer surfaces which may result in falsely elevated platelet results.
- Feb 20, 2019 · Class II · Z-1074-2019: There is a potential for the device to generate Quality Control (QC) low or out-of-range low for parameters RBC and PLT.
- Mar 24, 2016 · Class II · Z-1522-2016: Three lots of CELL-DYN Emerald Cleaner may have occurrences where the analyzer generates Quality Control Out of Range Low for parameters RBC and PLT.
- Oct 15, 2010 · Not classified · Z-1094-2011: There is the potential for the instrument to not power up due to the flash memory issue. This will result in an error message displayed is "No Memory Available" and has the potential for delay in gene
- Sep 30, 2010 · Not classified · Z-1668-2011: The product bar code label, when scanned, indicates that the volume is 10 mL rather than the correct volume of 10,000 mL. Analytical results are not impacted, although, there is a potential for delay 
- Mar 23, 2010 · Not classified · Z-1733-2011: Abbott has determined that gain settings for the non-standard specimen types may not match the gain settings for the standard specimen type. There is the potential for impact to product performance.
- Jul 16, 2009 · Not classified · Z-0065-2010: Software bug. The CELL-DYN Emerald WBC L1 flag is configured incorrectly. The flag is not generated according to system requirements.

## Indications for use
The CELL-DYN Emerald is an automated hematology analyzer designed for in-vitro diagnostic use in clinical laboratories.

Source page: https://510kreport.com/device/K081495
Methodology: https://510kreport.com/methodology