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Cell-Dyn Sapphire System

by Abbott Laboratories 510(k)

Active United States

510(k) K051215

Regulatory status

as of 27 Oct 2026

Recall ongoing. 1 ongoing FDA recall. See recalls

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK051215 Date21 Jul 2005ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

11 recalls · 1 ongoing · FDA

    • Ongoing Z-0604-2024 FDA Class II initiated 19 Oct 2023

    The devices contain a dry natural rubber (latex) subcomponent, which are not labeled as containing dry natural rubber(latex).

    • Terminated Z-2353-2010 FDA Unclassified (pre-2012) initiated 16 Apr 2010

    Epoxy holding the two parts of the waste reservoir together fails, potentially resulting in biohazardous fluid leaks.

    • Terminated Z-2421-2010 FDA Unclassified (pre-2012) initiated 5 Apr 2010

    Under certain conditions in closed mode of operations, the Aspiration Probe Detector PCB assembly may fail to operate properly and provide inaccurate results.

    • Terminated Z-1069-2009 FDA Unclassified (pre-2012) initiated 10 Dec 2008

    Some syringes were improperly assembled and are therefore not usable, due to an incorrect nut on the syringe shell.

    • Terminated Z-0306-2009 FDA Unclassified (pre-2012) initiated 25 Aug 2008

    Exposed wire resulted in minor electrical shock and burn to the service technician

    • Terminated Z-2139-2008 FDA Unclassified (pre-2012) initiated 11 Apr 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 nonsensical.

    • Terminated Z-1165-2008 FDA Unclassified (pre-2012) initiated 15 Jan 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 May 8, 2007 and November 29, 2007.

    • Terminated Z-1103-2008 FDA Unclassified (pre-2012) initiated 19 Dec 2007 via K051215, on the same 510(k)

    Microbial Contamination: The WBC (White Blood Cell) Reagent Part A was confirmed positive for Pseudomonas contamination.

    • Terminated Z-0301-2008 FDA Unclassified (pre-2012) initiated 25 Jul 2007

    Syringe Failure: Insufficient lubrication of the plunger tip may cause syringes to fail at installation or shortly thereafter

    • Terminated Z-0565-2007 FDA Unclassified (pre-2012) initiated 22 Dec 2006 via K051215, on the same 510(k)

    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.

    • Terminated Z-0708-2007 FDA Unclassified (pre-2012) initiated 17 Apr 2006 via K051215, on the same 510(k)

    High platelet background count when using the CELL-DYN 4000 System and/or CELL-DYN Sapphire System; with patient results unacceptable -out-of-range.

Recalls marked "via" name another device cleared under the same FDA submission as this one.

Specification

510(k)

510(k) Number
FDA Product Code
GKZ
Device Class
Class II
Regulation
21 CFR Part 864.5220
Advisory Committee
Hematology
FDA Decision
SESE Substantially Equivalent

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