510(k) Report

510(k) · Cleared

Recalled · Class II · 2023

Cell-Dyn Sapphire System

K051215510(k) TraditionalCleared Jul 21, 200570-day reviewClass II21 CFR 864.5220Recalls 11

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Abbott Laboratories · GKZ Counter, Differential Cell

Cleared on Jul 21, 2005 after a 70-day review. The FDA summary names its predicate without a number. It has been recalled 11 times.

Decided
Jul 21, 2005
Review
70 days
Class
Class II
Product code
GKZ
Recalls
11
Predicates
0

The FDA summary names its predicate without a number.

FIG. 1 — Lineage of K051215Source: FDA 510(k) database · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in GKZ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new GKZ device

  1. #1 K250943 Sysmex XR-Series (XR-10) Automated Hematology…score 13.2 · 3 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*—Abbott CELL-DYN 4000 System
Named without a submission number
—

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Oct 19, 2023Class IIZ-0604-2024Under Investigation by firmThe devices contain a dry natural rubber (latex) subcomponent, which are not labeled as containing dry natural rubber(latex).
Apr 16, 2010Not classifiedZ-2353-2010Nonconforming Material/ComponentEpoxy holding the two parts of the waste reservoir together fails, potentially resulting in biohazardous fluid leaks.
Apr 5, 2010Not classifiedZ-2421-2010OtherUnder certain conditions in closed mode of operations, the Aspiration Probe Detector PCB assembly may fail to operate properly and provide inaccurate results.
Dec 10, 2008Not classifiedZ-1069-2009Process controlSome syringes were improperly assembled and are therefore not usable, due to an incorrect nut on the syringe shell.
Aug 25, 2008Not classifiedZ-0306-2009Device DesignExposed wire resulted in minor electrical shock and burn to the service technician
Apr 11, 2008Not classifiedZ-2139-2008Software change controlTable 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 nonsensical.
Jan 15, 2008Not classifiedZ-1165-2008Process controlCount 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 May 8, 2007 and November 29, 2007.
Dec 19, 2007Not classifiedZ-1103-2008Material/Component ContaminationMicrobial Contamination: The WBC (White Blood Cell) Reagent Part A was confirmed positive for Pseudomonas contamination.
Jul 25, 2007Not classifiedZ-0301-2008Nonconforming Material/ComponentSyringe Failure: Insufficient lubrication of the plunger tip may cause syringes to fail at installation or shortly thereafter
Dec 22, 2006Not classifiedZ-0565-2007OtherResults 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, 2006Not classifiedZ-0708-2007OtherHigh platelet background count when using the CELL-DYN 4000 System and/or CELL-DYN Sapphire System; with patient results unacceptable -out-of-range.

The 5 latest of 11 recalls; the web page lists all.

No ancestor or descendant has a Class I recall.

How does its category compare?

All GKZ devices

GKZ Counter, Differential Cell: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GKZ

4in 2025

2007: 62008: 62009: 62010: 42011: 32012: 32013: 12014: 32015: 32016: 32017: 42018: 32019: 52020: 12022: 32023: 42024: 32025: 42026 (partial year): 4
2007high 6 (2007) · low 0 (2021)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GKZ

108in 2025

2007: 117 days median2008: 99 days median2009: 147 days median2010: 290 days median2011: 315 days median2012: 408 days median2014: 165 days median2015: 273 days median2016: 198 days median2017: 280 days median2018: 270 days median2019: 210 days median2022: 638 days median2023: 329 days median2024: 157 days median2025: 108 days median2026 (partial year): 254 days median
2007high 638 (2022) · low 99 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · GKZ

1in 2025

2007: 372008: 52009: 132010: 272011: 282012: 72013: 62015: 32016: 32017: 32018: 2, 2 Class I2019: 22020: 12022: 42023: 12025: 1
2007high 37 (2007) · low 0 (2014)2026

Class I (2 since 2007) Class II/III not classified

Adverse event reports per year · GKZ

77in 2025

2007: 2682008: 9252009: 5592010: 8962011: 2,9052012: 2,9592013: 3,0702014: 3,1122015: 1,9722016: 3,3382017: 2292018: 4972019: 9082020: 3422021: 3912022: 1982023: 1552024: 1152025: 77
2007high 3,338 (2016) · low 77 (2025)2025

MAUDE reports naming product code GKZ, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007611737268
20086995925
2009614713559
2010429027896
20113315282,905
2012340872,959
20131—63,070
2014316503,112
2015327331,972
2016319833,338
201742803229
201832702 (2)497
201952102908
20201—1342
20210—0391
202236384198
202343291155
202431570115
20254108177
202642540—

What is it indicated for?

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.

Indications for use as stated in the FDA summary.

More from Abbott Laboratories

1,433 FDA decisions under this applicant name. See the company

  • K262156Anti-HCV NextAbbott Laboratories · 2026
  • P120008/S032ARCHITECT AFP; Alinity i AFP (LN 3P36/07P90)Abbott Laboratories · 2026
  • K252424Anti-HCV NextAbbott Laboratories · 2026
  • P910007/S068ARCHITECT Total PSA / Alinity i Total PSA (LN 6C06/07P92)Abbott Laboratories · 2026
  • P910007/S067ARCHITECT Total PSA; Alinity i Total PSA (LN 6C06/07P92)Abbott Laboratories · 2026

Recent decisions in GKZ

The GKZ category page

  • K260781Yumizen H550Horiba Abx Sas · 2026
  • K253212XR-Series (XR-10, XR-20) Automated Hematology AnalyzersSysmex America, Inc. · 2026
  • K243348Athelas HomeAthelas, Inc. · 2026
  • K251249Tru Hematology TestTruvian Sciences, Inc. · 2026
  • K250943Sysmex XR-Series (XR-10) Automated Hematology AnalyzerSysmex America, Inc. · 2025

https://510kreport.com/device/K051215 · printed Nov 6, 2026

Cite this page

510(k) Report. “K051215: Cell-Dyn Sapphire System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051215

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Page last updated Nov 3, 2026