BEUDAMED
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    Cyberonics VNS Therapy AspireHC Model 105 Generator, 26-0007-4000/3. The firm name on the label is CYBERONICS, INC., Houston, TX. Vagus nerve stimulator.

    FDA Recall
    Terminated ·LivaNova USA Inc·Product code LYJ·November 16, 2018

    Cyberonics VNS Therapy AspireSR, Model 106 Generator, 26-0007-8400/1. The firm name on the label is CYBERONICS, INC., Houston, TX. Vagus nerve stimulator.

    FDA Recall
    Terminated ·LivaNova USA Inc·Product code LYJ·November 16, 2018

    Cyberonics VNS Therapy AspireHC Model 105 Generator, 26-0007-4000/3. The firm name on the label is CYBERONICS, INC., Houston, TX. Vagus nerve stimulator.

    FDA Enforcement
    Class II ·Terminated·LivaNova USA Inc·February 5, 2020

    The Operating Manual contains the Operating Instructions for AS 104 Blood Cell Separator and has a Software Version 4.71. The AS 104 Blood Cell Separator Device has a Catalog Number 9007031. Used for depletion or exchange of red blood cells during therapeutic apheresis procedures on the Fresenius AS 104 Blood Cell Separator Device. This set is used with a single stage separation chamber.

    FDA Recall
    Terminated ·Fresenius Kabi, LLC·Product code LKN·April 19, 2011

    Cyberonics VNS Therapy AspireSR, Model 106 Generator, 26-0007-8400/1. The firm name on the label is CYBERONICS, INC., Houston, TX. Vagus nerve stimulator.

    FDA Enforcement
    Class II ·Terminated·LivaNova USA Inc·February 5, 2020

    CELL-DYN 4000 Vent Head Spring Assembly, a component of the CELL-DYN 4000 Automated Hematology Analyzer, List Number 07H95-01, manufactured by Abbott Diagnostics Division, Santa Clara, CA Medical device component. The CELL-DYN 4000 System is a multiparameter automated hematology analyzer designed for in vitro diagnostic use in clinical laboratories. The vent head spring assembly is used in the auto-sampling mechanism on the CELL-DYN 4000.

    FDA Recall
    Terminated ·Abbott Laboratories·Product code GKZ·December 29, 2009

    BD Multi Check CD4 Low Control Catalog No. 340916 is intended as a complete process control for immunophenotyping by flow cytometry.

    FDA Recall
    Terminated ·BD Biosciences, Systems & Reagents·Product code GKZ·July 18, 2014

    Coulter AcT 5diff Open Vial Hematology Analyzers Part Numbers: 6605580, 6605581, 6605604

    FDA Recall
    Terminated ·Beckman Coulter Inc·Product code GKZ·September 8, 2003

    Cytomics FC 500 Flow Cytometry System with CXP Software Version 2.1 and 2.2 - SW Kit, CXP Analyis SW V2.2, 5 User Network, Automated differential cell counter; Part Number 774178; Beckman Coulter; Miami, FL 33196.

    FDA Recall
    Terminated ·Beckman Coulter Inc·Product code GKZ·May 4, 2007

    Cytomics FC 500 Flow Cytometry System with CXP Software Version 2.1 and 2.2 - CXP analysis SW V2.1 single user, Automated differential cell counter; Part Number 722396; Beckman Coulter; Miami, FL 33196.

    FDA Recall
    Terminated ·Beckman Coulter Inc·Product code GKZ·May 4, 2007

    Unicel DxH 800 Coulter Cellular Analysis System

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code GKZ·February 12, 2010

    Coulter LH 700 Series Hematology Analyzers

    FDA Recall
    Terminated ·Beckman Coulter Inc·Product code GKZ·January 10, 2003

    Abbott CELL-DYN 3500 Hematology Analyzer

    FDA Recall
    Terminated ·Abbott Laboratories·Product code GKZ·May 11, 2007

    COULTER AC-T 5diff Autoloader Hematology Analyzer, Part Number: 175356, Serial Numbers(s): All Serial Numbers The COULTER ACT-T 5diff Autoloader (AL) hematology analyzer is a 26-parameter, fully automated hematology analyzer, including a five-part leukocyte differential counter, capable of analyzing samples in a closed-vial Autoloader mode or a Manual (Stat) mode (open- or closed-vial).

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code GKZ·February 23, 2011

    Abbott CELL-DYN 3200 Hematology Analyzer CS (Closed Sampler), CELL-DYN 3200 SL (Sample Loader). Manufactured by Abbott Diagnostics Division, Santa Clara, Ca Medical Device, hematology analyzer for in vitro diagnostic use in clinical Laboratories.

    FDA Recall
    Terminated ·Abbott Laboratories·Product code GKZ·March 27, 2009

    CELL-DYN Shear Valve Assembly used on CELL-DYN 3200SL Analyzer and CELL-DYN 3200SL Analyzer (refurb). Abbott Diagnostics Division, Santa Clara, CA 05054 Designed for in vitro diagnostic use in clinical laboratories.

    FDA Recall
    Terminated ·Abbott Laboratories·Product code GKZ·March 15, 2011

    COULTER LH 780 Analyzer, part number: LH780 System Help 1B1.103272, PN 723585. SW Version: 1B1, 1B2. Serial Number: all. The COULTER LH 780 Hematology Analyzer is a quantitative, automated hematology analyzer and leukocyte differential counter For In Vitro Diagnostic Use in clinical laboratories. The COULTER LH 780 Hematology Analyzer also provides automated Reticulocyte analysis and enumeration of nucleated red blood cells (NRBCs) as well as an automated method for enumeration of RBCs and WBCs in body fluids.

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code GKZ·December 1, 2011

    Medonic M-Series Hematology Analyzer M16S BD ABR US Product code: 1400075; OUS Product code 1400011

    FDA Recall
    Terminated ·Clinical Diagnostic Solutions, Inc.·Product code GKZ·January 2, 2020

    First Check 7 Panel Drug Cup: (AMP/COC/MDMA/MET/OPI/PCP/THC); AMT Item Number 990100B

    FDA Recall
    Terminated ·Ameditech Inc·Product code DKZ·August 18, 2020

    ADVIA 560 Hematology Systems, Siemens Material Number (SMN) 11170842, IVD.

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code GKZ·October 21, 2016