BEUDAMED
    277 results · 13ms · Sources: EU EUDAMED, US FDA

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    VIDAS Chlamydia Assay (CHL) for In-Vitro Diagnostic Use Product Number: 30101

    FDA Recall
    Terminated ·bioMerieux·Product code LJC·August 6, 2003

    Cobas b 221 (versions 5 and 6) Blood Gas and Electrolytes Analyzer

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Operations, Inc.·February 11, 2015

    i-STAT EG7+ Cartridge; pH, PCO, PO, Na , K, iCa, Hct. Test include: Electrode Measurement Blood-Gases (Pco2, PO2) and Blood Ph, Electrode, Ion Specific, Potassium, Electrode, Ion Specific, Calcium, Electrode, ion Specific, Sodium and Hematocrit. Catalog number 220300. Abbott Point of Care inc., Abbott Park, IL 60064 USA Intended use is to quantify measurement of sodium, potassium, ionized calcium, oxygen, carbon dioxide, pH and Hematocrit in blood.

    FDA Recall
    Terminated ·Abbott Point of Care Inc.·Product code CHL·February 23, 2009

    Stat Profile Critical Care Xpress CCX+ Analyzer Catalog Number: 37413

    FDA Recall
    Terminated ·Nova Biomedical Corporation·Product code CHL·March 30, 2004

    i-STAT CK-MB cartridge Abbott Point of Care, Princeton, NJ 08540

    FDA Recall
    Terminated ·Abbott Point Of Care Inc.·Product code CHL·January 1, 2008

    Stat Profile Ultra Magnesium Sensor (In-vitro Diagnostic used with the Stat Profile Ultra M analyzer) Part # 20394

    FDA Recall
    Terminated ·Nova Biomedical Corporation·Product code CHL·September 22, 2003

    ABL700 Series analyzer - Human Blood Analyzer (Laboratory Device).

    FDA Recall
    Terminated ·Radiometer America Inc·Product code CHL·January 18, 2008

    The ABL software version 6.12 for the ABL800 and ABL700 analyzer. The analyzers are intended for the in Vitro testing of: -Samples of whole blood for the parameters pH, pO2, pCO2, cK+, cNa+, cCa2+, cCl-, cGlu, cLac, cCrea, ctBil, and co-oximetry parameters (ctHb, sO2, and the hemoglobin fractions FO2Hb, FCOHb, FMetHb, FHHb and FHbF) -Samples of expired air for the parameters pO2 and pCO2 -Pleura samples for the pH parameter. The ABL software version 6.12 for the ABL800 and ABL700 analyzer. The analyzers are intended for the in Vitro testing of: -Samples of whole blood for the parameters pH, pO2, pCO2, cK+, cNa+, cCa2+, cCl-, cGlu, cLac, cCrea, ctBil, and co-oximetry parameters (ctHb, sO2, and the hemoglobin fractions FO2Hb, FCOHb, FMetHb, FHHb and FHbF) -Samples of expired air for the parameters pO2 and pCO2 -Pleura samples for the pH parameter.

    FDA Recall
    Terminated ·Radiometer America Inc·Product code CHL·July 5, 2012

    ABL90 FLEX PLUS, model no. 393-02; and Spare Part Hemolyzer Units (902-980): R0526 - R0941 - Product Usage: are intended for use by trained technologists, nurses, physicians and therapists. It is intended for use in a laboratory environment, near patient or point-of-care setting.

    FDA Recall
    Terminated ·Radiometer Medical ApS Akandevej 21 Bronshoj Denmark·Product code CHL·November 21, 2019

    ABL800 FLEX, model number/UDI 393-800/0570 In Vitro testing of samples of whole blood for the parameters pH, pO2, pCO2, cK+, cNa+, cCa2+, cCl , cGlu, cLac, cCrea, ctBil, and co-oximetry parameters (ctHb, sO2, and the hemoglobin fractions FO2Hb, FCOHb, FMetHb, FHHb and FHbF) In vitro testing of samples of expired air for the parameters pO2 and pCO2 In vitro testing of pleura samples for the pH parameter.0693938004 and 393-801/05700693938011 - Product Usage:

    FDA Recall
    Terminated ·Radiometer Medical ApS Akandevej 21 Bronshoj Denmark·Product code CHL·March 10, 2020

    Abbott i-STAT EG7+ cartridge-IVD. Intended for the quantitative measurement of sodium, potassium, ionized calcium, pH, pCO2, pO2 and hematocrit in venous, arterial or capillary whole blood. List Number: 03P76-25

    FDA Recall
    Terminated ·Abbott Point Of Care Inc.·Product code CHL·December 22, 2020

    Waste bottles Part Numbers/Article Numbers: 905-590/D512 and 905-802/D513. The waste bottles are used to collect waste from the ABL7XX and the ABL8XX blood gas analyzer after rinsing.

    FDA Recall
    Terminated ·Radiometer America Inc·Product code CHL·April 16, 2009

    Stat Profile Critical Care Xpress (CCX) Analyzer Catalog Number: 35942

    FDA Recall
    Terminated ·Nova Biomedical Corporation·Product code CHL·March 30, 2004

    GEM Premier 4000 Laboratory Analyzer

    FDA Recall
    Terminated ·Instrumentation Laboratory Co.·Product code CHL·March 27, 2007

    Reference Electrodes for ABL 700/800 Blood Gas Analyzers. Electrode Part Number: 945-603, distributed one (1) electrode per box.

    FDA Recall
    Terminated ·Radiometer America Inc·Product code CHL·September 19, 2005

    ABL 800 FLEX series blood gas analyzers containing software version 5.24.

    FDA Recall
    Terminated ·Radiometer America Inc·Product code CHL·November 13, 2006

    ABL77 Cal Pack, Model Number 944-069, Lot Number 17323, SenDx Medical Inc., A Radiometer Company

    FDA Recall
    Terminated ·Sendx Medical Inc·Product code CHL·June 19, 2007

    Pump waste tube for blood gas analysis kit. One yellowish/white rubber tube per plastic bag. Used on ABL800 Flex Series blood gas analyzers.

    FDA Recall
    Terminated ·Radiometer America Inc·Product code CHL·June 22, 2007

    Dri-Tek BG-OX Cartridge, Model #D7120, Cat. #946-003 Cartridges used in the NPT7 Analyzer, an in vitro diagnostic device.

    FDA Recall
    Terminated ·Radiometer America Inc·Product code CHL·May 1, 2006

    FUSO Analyzer 300F Abbott Point of Care, Princeton, NJ 08540 Model 200. the 37 degree 37 degree C tests for sodium, potassium, ionized calcium, hematocrit, pH, PCO2, PO2 and the i-stat portable analyzer as part of the i-STAT system, are intended for use in the in vitro quantization of arterial, venous or capillary whole blood.

    FDA Recall
    Terminated ·Abbott Point Of Care Inc.·Product code CHL·September 20, 2010