BEUDAMED
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    Abbott CELL-DYN 3000CS (Closed Sampler), CELL-DYN 3000SL (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

    Abbott CELL-DYN 1700 Analyzer, CELL-DYN 1700 CS (Closed Sample).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

    VIDAS TOXO IgG Avidity is an automated qualitative test for use on the VIDAS family instruments, for the determination of anti-toxoplasma IgG avidity in human serum or plasma (lithium heparin, sodium citrate, EDTA) using the ELFA technique (Enzyme Linked Fluorescent Assay). Toxoplasma gondii serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to Toxoplasma gondii in serum. Additionally, some of these reagents consist of antisera conjugated with a fluorescent dye (immunofluorescent reagents) used to identify Toxoplasma gondii from clinical specimens.

    FDA Enforcement
    Class II ·Terminated·BioMerieux SA·June 20, 2018

    GYRUS ACMI, REF 3740, Everest BiCOAG Bipolar Dissecting Forceps 5mm/45 cm, Sterile EO. GYRUS ACMI, REF 3740PK, or REF 94201PK, PKS LYONS, Dissecting Forceps 5mm/45cm, Sterile EO. The Dissectors are sterile, single use electrosurgical devices that are indicated for the electrosurgical coagulation, mechanical grasping, and dissection of tissue during the performance of laparoscopic and general surgical procedures.

    FDA Enforcement
    Class II ·Terminated·Gyrus Medical, Inc·August 28, 2013

    Abbott brand CELL-DYN Emerald, CELL-DYN Emerald CPU Board Hematology System; List Number: 09H39-01; Field Replaceable Unit (FRU) Numbers: 8701686901, 8701686902; Product is distributed by Abbott Diagnostics Division, Santa Clara. CA and manufactured in France for Abbott Diagnostics Division of Abbott Laboratories, Abbott Park, IL Intended use: The CELL-DYN Emerald is an automated hematology analyzer designed for in-vitro diagnostic use in clinical laboratories.

    FDA Recall
    Terminated ·Abbott Laboratories·Product code GKZ·October 15, 2010

    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

    Abbott CELL-DYN 3500 Hematology Analyzer CS (Closed Sampler), CELL-DYN 3500 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

    White Blood Cell (WBC) Reagent-Part A used with the CELL-DYN 4000 and CELL-DYN Sapphire Systems, Red cell lysing reagent, List Number 01H77-01, Supplied in 3.8L bottles, Abbott Laboratories, Abbott Park, IL 60064

    FDA Recall
    Terminated ·Abbott Laboratories·Product code GGK·December 19, 2007

    Abbott CELL-DYN 3700 Hematology Analyzer CS (Closed Sampler), , and CELL-DYN 3700 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

    Emerald Diluent Tubing, List number 09H50-01, accompanying CELL-DYN Emerald instrument, List number 09H39-01. The firm name on the label is Abbott Laboratories, Abbott Park, IL.

    FDA Enforcement
    Class II ·Terminated·Abbott Laboratories·October 30, 2019

    Abbott CELL-DYN 3500 Hematology Analyzer

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

    Abbott CELL-DYN 3000 Hematology Analyzer

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

    Abbott CELL-DYN 3700 Hematology Analyzer

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

    The PREVI¿ Color Gram dyes are used with the PREVI¿ Color Gram instrument to stain bacterial and fungal microorganisms for direct examination, according to Gram s method. The PREVI¿ Color Gram instrument sprays the PREVI¿ Color Gram reagents onto microscope slides which have been smeared with specimens to be examined. The staining procedure is rapid and precise. Each reagent has a specific position (A, B, C, D, E) on the PREVI¿ Color Gram platform that is also indicated on the reagent label. An automated slide stainer is a device used to stain histology, cytology, and hematology slides for diagnosis.

    FDA Enforcement
    Class II ·Terminated·BioMerieux SA·June 20, 2018

    Abbott brand CELL-DYN Emerald Hematology Analyzer System; List Numbers: 09H39-01; The product is manufactured in France for Abbott Diagnostics Division of Abbott Laboratories, Abbott Park, IL The CELL-DYN Emerald is an automated hematology analyzer designed for in-vitro diagnostic use in clinical laboratories.

    FDA Recall
    Terminated ·Abbott Laboratories·Product code GKZ·March 23, 2010

    Abbott brand CELL-DYN Emerald Diluent Reagent, 10 mL, List Number: 09H48-02, Product is manufactured and distributed by Abbott Diagnostics Division, Santa Clara. CA Designed for use on the CELL-DYN Emerald System, which is an automated hematology analyzer designed for in-vitro diagnostic use in clinical laboratories.

    FDA Recall
    Terminated ·Abbott Laboratories·Product code GKZ·September 30, 2010

    CELL-DYN CD 3/4/8 Assay Reagents for Sapphire Hematology Analyzer

    FDA Recall
    Terminated ·Abbott Laboratories·Product code GKZ·December 16, 2005

    CELL-DYN Sheer Valve Assembly Driver Abbott Diagnostics Division, Santa Clara, CA 05054

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

    Color Gram 2 (COLOR GRAM 2 - F), these stains are used to stain bacterial and fungal microorganisms for direct examination, according to the Gram method. Dye and chemical solution stains for medical purposes are mixtures of synthetic or natural dyes or nondye chemicals in solutions used in staining cells and tissues for diagnostic histopathology, cytopathology, or hematology.

    FDA Recall
    Terminated ·BioMerieux SA Chemin De L'Orme Marcy L'Etoile France·Product code JTS·March 23, 2018

    CELL-Dyn Ruby Hematology Analyzer, List Number 08H67-01 The CELL-DYN Ruby is a multi-parameter, automated hematology analyzer designed for in vitro diagnostic use in clinical laboratories. The instrument has two modes of operation: the Autoloader mode that aspirates samples from closed collection tubes and the Open Tube mode that aspirates samples from open collection tubes.

    FDA Recall
    Terminated ·Abbott Laboratories·Product code GKZ·November 17, 2008