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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 Multitest 6-Color TBNK CE-IVD, REF: 644611; BD Multitest 6-Color TBNK Kit with BD Trucount Tubes CE-IVD, REF: 337166; BD Multitest 6-Color TBNK, IVD, REF: 662967; BD Multitest 6-Color TBNK Kit with BD Trucount Tubes IVD, REF: 662995. BD Multitest" 6-Color TBNK reagent with optional BD Trucount" Tubes is a six-color direct immunofluorescence reagent.

    FDA Recall
    Open, Classified ·Becton, Dickinson and Company, BD Biosciences·Product code OYE·May 8, 2024

    FACSLyric 3L12C Instrument RUO, Catalog Number 663518, UDI 00382906635181

    FDA Recall
    Open, Classified ·Becton, Dickinson and Company, BD Bio Sciences·Product code OYE·November 1, 2024

    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

    FACSLyric 3L10C Instrument US-IVD, Catalog Number 662878, UDI 00382906628787 The K170974 clearance document describes the device as follows: The BD FACSLyric" flow cytometer (3-1, 4-2, 4-2-2, and 4-3-3 optical configurations) systems consist of a flow cytometer, sheath tank, waste tank, and a computer workstation. System options include an automated FACS Universal Loader and a barcode reader. The BD FACSLyric Flow Cytometer includes the 488 nm laser and 640 nm laser as part of four available manufactured instrument configurations. BD FACSLyric Flow Cytometer, 3-1 configuration, 4-color/2-laser BD FACSLyric Flow Cytometer, 4-2 configuration, 6-color/2-laser BD FACSLyric Flow Cytometer, 4-2-2 configuration, 8-color/3-laser BD FACSLyric Flow Cytometer, 4-3-3 configuration, 10-color/3-laser The lower level configurations are upgradeable to higher level configurations by adding filters, photomultiplier tubes (PMTs), and a laser. Only the 488 nm laser and 640 nm lasers are utilized for cleared in vitro diagnostic (IVD) applications and only fluorescence channels 1 (FL1) through FL6 are the subject of this 510(k) submission. Seven to tencolor immunophenotyping is for research use only (RUO). All optical configurations of the FACSLyric share the same dimensions: 22.8 inches in height by 24.93 inches in width by 22.8 inches in depth. The K201814 clearance document describes the device as follows: Refer to K170974 for detailed description and functioning of the BD FACSLyric flow cytometer. The modified BD FACSLyric Flow Cytometer consists of the following components. " FACSLyric Flow Cytometer (3-1, 4-2, 4-2-2 ,4-3-3 and 4-3-5 optical configurations) " FACSuite Clinical Software (version 1.4) " Modified FACS Universal Loader: updated shaker and modification to the door lock and sensor connections " Modified CMS firmware BD FACSLyric Flow Cytometer with the integrated BD FACSDuet Sample Preparation system consists of all the above components as FACSLyric Flow Cytometer and additionally contain: " BD FACSDuet Sample Preparation system physically and data integrated with the BD FACSLyric Flow Cytometer " FACSDuet fluidics that contain saline, deionized (DI) water and 10% bleach solution. " Modified FACS Universal Loader: updated shaker, modification to the door lock and sensor connections, addition of stabilization bracket

    FDA Recall
    Open, Classified ·Becton, Dickinson and Company, BD Bio Sciences·Product code OYE·November 1, 2024

    Device Description: FACSLyric 2L6C Instrument US, Catalog Number 662876, UDI 00382906628763 The K170974 clearance document describes the device as follows: The BD FACSLyric" flow cytometer (3-1, 4-2, 4-2-2, and 4-3-3 optical configurations) systems consist of a flow cytometer, sheath tank, waste tank, and a computer workstation. System options include an automated FACS Universal Loader and a barcode reader. The BD FACSLyric Flow Cytometer includes the 488 nm laser and 640 nm laser as part of four available manufactured instrument configurations. BD FACSLyric Flow Cytometer, 3-1 configuration, 4-color/2-laser BD FACSLyric Flow Cytometer, 4-2 configuration, 6-color/2-laser BD FACSLyric Flow Cytometer, 4-2-2 configuration, 8-color/3-laser BD FACSLyric Flow Cytometer, 4-3-3 configuration, 10-color/3-laser The lower level configurations are upgradeable to higher level configurations by adding filters, photomultiplier tubes (PMTs), and a laser. Only the 488 nm laser and 640 nm lasers are utilized for cleared in vitro diagnostic (IVD) applications and only fluorescence channels 1 (FL1) through FL6 are the subject of this 510(k) submission. Seven to tencolor immunophenotyping is for research use only (RUO). All optical configurations of the FACSLyric share the same dimensions: 22.8 inches in height by 24.93 inches in width by 22.8 inches in depth. The K201814 clearance document describes the device as follows: Refer to K170974 for detailed description and functioning of the BD FACSLyric flow cytometer. The modified BD FACSLyric Flow Cytometer consists of the following components. " FACSLyric Flow Cytometer (3-1, 4-2, 4-2-2 ,4-3-3 and 4-3-5 optical configurations) " FACSuite Clinical Software (version 1.4) " Modified FACS Universal Loader: updated shaker and modification to the door lock and sensor connections " Modified CMS firmware BD FACSLyric Flow Cytometer with the integrated BD FACSDuet Sample Preparation system consists of all the above components as FACSLyric Flow Cytometer and additionally contain: " BD FACSDuet Sample Preparation system physically and data integrated with the BD FACSLyric Flow Cytometer " FACSDuet fluidics that contain saline, deionized (DI) water and 10% bleach solution. " Modified FACS Universal Loader: updated shaker, modification to the door lock and sensor connections, addition of stabilization bracket

    FDA Recall
    Open, Classified ·Becton, Dickinson and Company, BD Bio Sciences·Product code OYE·November 1, 2024

    DxFLEX Flow Cytometer Catalog Number C78500 UDI-DI code: 15099590754013 The DxFLEX Flow Cytometer is intended for use as an in vitro diagnostic device for immunophenotyping up to ten fluorescent detection channels using three lasers (488 nm, 638 nm and 405 nm) and two light scatter detection channels. It is intended for use with in vitro diagnostic (IVD) assays and software that are indicated for use with the instrument.

    FDA Recall
    Open, Classified ·Beckman Coulter Inc.·Product code OYE·September 22, 2025

    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