# K051215: Cell-Dyn Sapphire System

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Laboratories
- Decided: Jul 21, 2005 after 70 days
- Product code: GKZ (Counter, Differential Cell)
- Device class: 2
- Regulation: 21 CFR 864.5220
- Recalls of this device: 11 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Abbott CELL-DYN 4000 System: named in the summary without a submission number

## Recalls of this device
- 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).
- Apr 16, 2010 · Not classified · Z-2353-2010: Epoxy holding the two parts of the waste reservoir together fails, potentially resulting in biohazardous fluid leaks.
- Apr 5, 2010 · Not classified · Z-2421-2010: Under certain conditions in closed mode of operations, the Aspiration Probe Detector PCB assembly may fail to operate properly and provide inaccurate results.
- Dec 10, 2008 · Not classified · Z-1069-2009: Some syringes were improperly assembled and are therefore not usable, due to an incorrect nut on the syringe shell.
- Aug 25, 2008 · Not classified · Z-0306-2009: Exposed wire resulted in minor electrical shock and burn to the service technician
- Apr 11, 2008 · Not classified · Z-2139-2008: Table in LIS Specification depicting the association between Record ID and Numerical Result Label is incorrect. If a record ID is used to configure the system for mapping, results will come out nonsen
- Jan 15, 2008 · Not classified · Z-1165-2008: Count may be out of specification--Hemoglobin background count may be out of specification (high) after installation of new CELL-DYN Sapphire Hemoglobin Reagent Syringes with packaging dates between M
- Dec 19, 2007 · Not classified · Z-1103-2008: Microbial Contamination: The WBC (White Blood Cell) Reagent Part A was confirmed positive for Pseudomonas contamination.
- Jul 25, 2007 · Not classified · Z-0301-2008: Syringe Failure: Insufficient lubrication of the plunger tip may cause syringes to fail at installation or shortly thereafter
- 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.

## Indications for use
The CELL-DYN Sapphire System is a multiparameter, automated hematology analyzer designed to provide complete blood count with WBC Differential, NRBC, Reticulocyte and Immature Reticulocyte Fraction enumeration, and CD61 and CD3/4/8 immunofluorescent analysis on EDTA-anticoagulated whole blood.

Source page: https://510kreport.com/device/K051215
Methodology: https://510kreport.com/methodology