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    AQUIOS CL Flow Cytometer, Ref no. B30166, Software Versions 2.0 and 2.0.1 Product Usage: The AQUIOS CL Flow Cytometer is intended for use with in vitro diagnostic flow cytometric applications using up to four fluorescent detection channels using a blue (488 nm) laser, two light scatter detection channels and electronic volume (EV).

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code OYE·April 3, 2017

    BD FACSLyric Flow Cytometer, 3-Laser 12 Color Instrument, REF: 663029, when using BD Trucount Tubes

    FDA Recall
    Terminated ·Becton, Dickinson and Company, BD Biosciences·Product code OYE·August 19, 2019

    BD FACSLyric Flow Cytometer, 2-Laser 6 Color Instrument, REF: 662876, when using BD Trucount Tubes

    FDA Recall
    Terminated ·Becton, Dickinson and Company, BD Biosciences·Product code OYE·August 19, 2019

    BD FACSLyric Flow Cytometer, 2-Laser 6 Color Instrument, REF: 651165, when using BD Trucount Tubes

    FDA Recall
    Terminated ·Becton, Dickinson and Company, BD Biosciences·Product code OYE·August 19, 2019

    BD FACSLyric Flow Cytometer, 3-Laser 8 Color Instrument, REF: 654587, when using BD Trucount Tubes

    FDA Recall
    Terminated ·Becton, Dickinson and Company, BD Biosciences·Product code OYE·August 19, 2019

    AQUIOS Lyse Reagent Kit, Catalog No. B23538 Product Usage: AQUIOS Lysing Reagent Kit is used as part of the AQUIOS flow cytometer system. The kit consists of two reagents used by AQUIOS flow cytometers to prepare whole blood samples for analysis of white blood cells.

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code OYE·October 19, 2016

    BD FACS Canto and associated Fluidics Cart Product Usage: Flow cytometer for use in In vitro Diagnostics.

    FDA Recall
    Terminated ·BD Biosciences, Systems & Reagents·Product code OYE·June 6, 2014

    AQUIOS CL Flow Cytometer, Catalog No. B30166, Rx. The firm name on the label is Beckman Coulter Ireland Inc., Ireland. The AQUIOS CL Flow Cytometer is intended for use as an in vitro diagnostic device for immunophenotyping. It is used in conjunction with the following reagents and software package: AQUIOS Tetra-1 Panel monoclonal antibody reagents, AQUIOS Tetra-2+ Panel monoclonal antibody reagents, and AQUIOS CL Flow Cytometry Software.

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code OYE·October 2, 2017

    AQUIOS CL Flow Cytometer System The AQUIOS CL Flow Cytometer is intended for use as an in vitro diagnostic device for immunophenotyping.

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code OYE·August 21, 2017

    BD FACSLyric Flow Cytometer, 2-Laser 4 Color Instrument, REF: 662875, when using BD Trucount Tubes

    FDA Recall
    Terminated ·Becton, Dickinson and Company, BD Biosciences·Product code OYE·August 19, 2019

    BD FACS Universal Loader (Optional) to the BD FACSLyric Clinical System, Model 662879 (Universal Loader), Rx Only. The firm name on the label is Becton, Dickinson and Company, BD Biosciences, San Jose, CA. The Loader offers various settings to resuspend and mix samples. It can draw from 12 x 75-mm tubes in 30- and 40-tube racks. A barcode reader verifies the ID on tube racks and individual tubes in 30- tube racks. A built-in imaging system provides safety checks, such as verifying the correct rack type and tube layout, and ensures the tubes were loaded correctly.

    FDA Recall
    Terminated ·Becton, Dickinson and Company, BD Biosciences·Product code OYE·May 16, 2018

    BD FACSLyric Flow Cytometer, 3-Laser 8 Color Instrument, REF: 662877, when using BD Trucount Tubes

    FDA Recall
    Terminated ·Becton, Dickinson and Company, BD Biosciences·Product code OYE·August 19, 2019

    BD FACSLyric Flow Cytometer,3-Laser 10 Color Instrument, REF: 659180 and 65918001, when using BD Trucount Tubes

    FDA Recall
    Terminated ·Becton, Dickinson and Company, BD Biosciences·Product code OYE·August 19, 2019

    BD FACSLyric Flow Cytometer, 3-Laser 10 Color Instrument, REF: 662878, and 66287808 when using BD Trucount Tubes

    FDA Recall
    Terminated ·Becton, Dickinson and Company, BD Biosciences·Product code OYE·August 19, 2019

    BD FACSLyric Flow Cytometer, 2-Laser 4 Color Instrument, REF: 651164, when using BD Trucount Tubes

    FDA Recall
    Terminated ·Becton, Dickinson and Company, BD Biosciences·Product code OYE·August 19, 2019

    AQUIOS CL Flow Cytometer System, Catalog #B30166. The AQUIOS CL Flow Cytometer system is an automated analyzer that use a no-wash sample preparation process.The firm name on the label is Beckman Coulter Ireland, Inc., Co. Clare, Ireland.

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code OYE·January 29, 2018

    BD FACSLyric 3L 10C with FACSuite Clinical Software v1.1.1, catalog number 662878 BD FACSLyric is a high-performance flow cytometer designed to support both routine clinical analysis and research for the identification, quantification, and characterization of cells in support of cell analysis. BD FACSuite software is loaded onto an adjacent PC workstation and is used to operate the instrument, acquire samples, and analyze data. Quality control performance, tracking, and reporting are streamlined and automated. Routine tasks such as daily cleaning and shutdown can be programmed to occur automatically. The BD FACSuite clinical software allows users to run BD IVD assays.

    FDA Recall
    Terminated ·Becton, Dickinson and Company, BD Biosciences·Product code OYE·January 2, 2019

    BD FACSCalibur; Catalog Numbers 342973, 342975, 34976 In vitro Diagnostics Use.

    FDA Recall
    Terminated ·BD Biosciences, Systems & Reagents·Product code OYE·March 6, 2015

    AQUIOS CL Flow Cytometer, Catalog No. B30166; Intended for use with in vitro diagnostic flow cytometry applications using up to four florescent detection channels.

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code OYE·September 6, 2016

    Multilite Dye Handpieces, an optional accessory of the RevLite SI Laser. The Revlite SI laser is intended for General Dermatology, Dermatologic and General Surgical Procedures. Which includes treatments such as tattoo removal, pigmented lesion removal, removal or lightening of hair, skin resurfacing and reduction of red pigmentation in hypertropic and keloid scars The two Multilite Dye Handpieces (HPs) are optional handpieces that can be used with the Revlite SI Laser. Manufactured by: ConBio, A Cynosure Company 47733 Fremont blvd Fremont, CA 94538

    FDA Enforcement
    Class II ·Terminated·ConBio, a CynoSure Company·July 3, 2013