BEUDAMED
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    VACUETTE Tube 2ml 9NC Coagulation Sodium Citrate 3.2%. Item no. 454322. Lot no. B1908355.

    FDA Enforcement
    Class II ·Terminated·Greiner Bio-One North America, Inc.·April 22, 2020

    The VITEK¿ 2 Anaerobic and Corynebacteria identification card (ANC) is intended for use with the VITEK¿ 2 Systems for the automated identification of most clinically significant anaerobic organisms and Corynebatcerium species. The VITEK¿ 2 ANC identification card is a single-use disposable. A microorganism differentiation and identification device is a device intended for medical purposes that consists of one or more components, such as differential culture media, biochemical reagents, and paper discs or paper strips impregnated with test reagents, that are usually contained in individual compartments and used to differentiate and identify selected microorganisms. The device aids in the diagnosis of disease.

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

    VACUETTE Tube 2ml 9NC Coagulation Sodium Citrate 3.2%. Item no. 454322. Lot no. B1908355.

    FDA Recall
    Terminated ·Greiner Bio-One North America, Inc.·Product code GIM·March 12, 2020

    VACUETTE¿ Blood Collection tube 9NC Coagulation sodium citrate 3.2% 13x75 blue cap-white ring, sandwich tube, non-ridged - Product Usage: indicated for use in collection and transport of venous whole blood for coagulation testing.

    FDA Enforcement
    Class II ·Terminated·Greiner Bio-One North America, Inc.·May 12, 2021

    BD Vacutainer Buffered Sodium Citrate: (9NC) Blood Collection Tubes, 4.5 mL, 13 x 75 mm, Mfd: Becton Dickinson and Company Product Usage: The BD Vacutainer Safety Coagulation tube is an evacuated blood collection Tube that provides means of collecting, transporting and processing blood in a closed tube. The buffered sodium citrate additive provides an anti-coagulated specimen that may be used for clinical laboratory coagulation assays and determinations.

    FDA Recall
    Terminated ·Becton Dickinson & Company·Product code JKA·March 16, 2017

    EM2+A NC AEM Monotor (NON-COM)

    FDA Recall
    Terminated ·Encision, Inc.·Product code GEI·June 23, 2003

    Greiner bio-one, VACUETTE TUBE, 9NC Coagulation Citrate 3.2%, 3.5ml blue cap-black ring, 24 racks of 50, 1200 pcs in total, non ridged, sandwich tube, Ref: 454332, Lot B040404, Expiry 2005-04, Sterile.

    FDA Recall
    Terminated ·Greiner VACUETTE North America·Product code GIM·July 27, 2004

    3mL 9NC Coagulation Sodium Citrate 3.2%, Item #454334, Greiner Bio-One North America Inc., 4238 Capital Drive, Monroe, NC 28110. Intended Use: Venous blood collection tubes.

    FDA Enforcement
    Class II ·Terminated·Greiner Bio-One North America, Inc.·August 15, 2012

    Greiner Bio-One VACUETTE¿ TUBE 2 ml 9NC Coagulation sodium citrate 3.2% 13x75 blue cap-white ring, sandwich tube, non-ridged

    FDA Enforcement
    Class II ·Terminated·Greiner Bio-One North America, Inc.·September 29, 2021

    VITEK 2 Anaerobic and Corynebacteria identification card (ANC), REF 21347, 20 cards per carton.

    FDA Enforcement
    Class II ·Terminated·Biomerieux Inc·June 21, 2017

    BD Vacutainer Buffered Sodium Citrate: (9NC) Blood Collection Tubes, 4.5 mL, 13 x 75 mm, Mfd: Becton Dickinson and Company Product Usage: The BD Vacutainer Safety Coagulation tube is an evacuated blood collection Tube that provides means of collecting, transporting and processing blood in a closed tube. The buffered sodium citrate additive provides an anti-coagulated specimen that may be used for clinical laboratory coagulation assays and determinations.

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Company·April 12, 2017

    BD Vacutainer Buffered Sodium Citrate (9NC) Plus Blood Collection Tubes; Sterile; IVD; REF 363083; 13 X 75 mm, 2.7 mL

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Company·February 6, 2013

    VITEK 2 Anaerobic and Corynebacteria identification card (ANC), REF 21347, 20 cards per carton.

    FDA Recall
    Terminated ·Biomerieux Inc·Product code JSP·April 20, 2017

    ThermaCor 1200 Disposable Sets Components of the Smisson-Cartledge Biomedical ThermaCor 1200 Rapid Thermal Infusion System, used for infusion of: -crystalloid, colloid, or blood product, including packed red blood cells, as volume replacement for patients suffering from blood loss due to trauma or surgery -warmed fluid to rewarm patients after surgery or hypothermia -warmed fluid for irrigation in urology procedures

    FDA Enforcement
    Class I ·Terminated·Smisson-Cartledge Biomedical, LLC·April 7, 2021

    BD Vacutainer Buffered Sodium Citrate: (9NC) Blood Collection Tube (4.5 ml x 13 x 75 mm) Catalog Number: 369714 Product Usage: The BD Vacutainer Safety Coagulation tube is an evacuated blood collection tube that provides means of collecting, transporting and processing blood in a closed tube. The buffered sodium citrate additive provides an anti-coagulated specimen that may be used for clinical laboratory coagulation assays and determinations

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Company·February 22, 2017

    BD Vacutainer Buffered Sodium Citrate (9NC) Plus Blood Collection Tubes; Sterile; IVD; REF 363083; 13 X 75 mm, 2.7 mL

    FDA Recall
    Terminated ·Becton Dickinson & Company·Product code JKA·November 12, 2012

    Greiner Bio-One VACUETTE TUBE 2 ml 9NC Coagulation sodium citrate 3.2% 13x75 blue cap-white ring, sandwich tube, non-ridged

    FDA Recall
    Terminated ·Greiner Bio-One North America, Inc.·Product code GIM·August 20, 2021

    VACUETTE Blood Collection tube 9NC Coagulation sodium citrate 3.2% 13x75 blue cap-white ring, sandwich tube, non-ridged - Product Usage: indicated for use in collection and transport of venous whole blood for coagulation testing.

    FDA Recall
    Terminated ·Greiner Bio-One North America, Inc.·Product code GIM·March 29, 2021

    3mL 9NC Coagulation Sodium Citrate 3.2%, Item #454334, Greiner Bio-One North America Inc., 4238 Capital Drive, Monroe, NC 28110. Intended Use: Venous blood collection tubes.

    FDA Recall
    Terminated ·Greiner Bio-One North America, Inc.·Product code GIM·July 2, 2012

    The VITEK 2 Anaerobic and Corynebacteria identification card (ANC) is intended for use with the VITEK 2 Systems for the automated identification of most clinically significant anaerobic organisms and Corynebatcerium species. The VITEK 2 ANC identification card is a single-use disposable. A microorganism differentiation and identification device is a device intended for medical purposes that consists of one or more components, such as differential culture media, biochemical reagents, and paper discs or paper strips impregnated with test reagents, that are usually contained in individual compartments and used to differentiate and identify selected microorganisms. The device aids in the diagnosis of disease.

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