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Cell-Dyn Emerald System

by Abbott Laboratories 510(k)

Active United States

510(k) K081495

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK081495 Date4 Feb 2009ClearedStatusActive

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
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  • Expiring
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United States — FDA 510(k) Active

Recalls

7 recalls · FDA

    • Terminated Z-0173-2020 FDA Class II initiated 9 May 2019

    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.

    • Terminated Z-1074-2019 FDA Class II initiated 20 Feb 2019

    There is a potential for the device to generate Quality Control (QC) low or out-of-range low for parameters RBC and PLT.

    • Terminated Z-1522-2016 FDA Class II initiated 24 Mar 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.

    • Terminated Z-1094-2011 FDA Unclassified (pre-2012) initiated 15 Oct 2010

    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 generating patient results.

    • Terminated Z-1668-2011 FDA Unclassified (pre-2012) initiated 30 Sep 2010

    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 in generating results.

    • Terminated Z-1733-2011 FDA Unclassified (pre-2012) initiated 23 Mar 2010

    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.

    • Terminated Z-0065-2010 FDA Unclassified (pre-2012) initiated 16 Jul 2009

    Software bug. The CELL-DYN Emerald WBC L1 flag is configured incorrectly. The flag is not generated according to system requirements.

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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