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Cell-Dyn Ruby System

by Abbott Laboratories 510(k)

Active United States

510(k) K061667

Regulatory status

as of 27 Oct 2026

Recall ongoing. 6 ongoing FDA recalls. See recalls

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK061667 Date10 Jul 2006ClearedStatusActive

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

12 recalls · 6 ongoing · FDA

  • 5 recalls, same reason

    • Ongoing Z-1654-2025 FDA Class II initiated 18 Mar 2025
    • Ongoing Z-1655-2025 FDA Class II initiated 18 Mar 2025
    • Ongoing Z-1652-2025 FDA Class II initiated 18 Mar 2025
    • Ongoing Z-1656-2025 FDA Class II initiated 18 Mar 2025
    • Ongoing Z-1653-2025 FDA Class II initiated 18 Mar 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 reagents is against the guidelines of the Operator's Manual.

    • 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-1438-2017 FDA Class II initiated 13 Feb 2017

    The Pump Relay Printed Circuit Board Assembly (PCBA) used in the CELL-DYN Ruby instrument may prematurely fail and lead to instrument stoppage

    • Terminated Z-2019-2011 FDA Unclassified (pre-2012) initiated 15 Mar 2011

    The Nylon Washer has an outer diameter which is undersized resulting in the inability to generate patient results.

    • Terminated Z-2352-2010 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-1398-2009 FDA Unclassified (pre-2012) initiated 12 Feb 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, burns may occur.

    • Terminated Z-1064-2009 FDA Unclassified (pre-2012) initiated 17 Nov 2008

    Carryover failures in software revisions 1.0ML and 2.0ML result in elevated PLT background count.

    • Terminated Z-0565-2007 FDA Unclassified (pre-2012) initiated 22 Dec 2006 via K061667, 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.

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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