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    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

    pCO2 D788 Membranes. Distributed by Radiometer America, Inc., Westlake, OH. An automatic or semi-automatic instrument used to identify and quantify two or more gases, and sometimes electrolytes, in whole blood using multiple special electrodes.

    FDA Recall
    Terminated ·Radiometer America Inc·Product code CHL·July 5, 2013

    pO2 D999 membrane units. Distributed by Radiometer America, Inc., Westlake, OH 44145 pO2 membrane units, ordering number 942-042 Intended use is in vitro testing of samples of whole blood for pO2 (partial pressure of oxygen).

    FDA Recall
    Terminated ·Radiometer America Inc·Product code CHL·June 10, 2013

    TCM CombiM Modules 903-111

    FDA Recall
    Terminated ·Radiometer America Inc·Product code LKD·November 18, 2015

    S1827 Crea Calibration solution 1, 944-135, Lot DV-02 Radiometer Medical, Bronshoj Denmark Product Usage: The S1827 Crea Calibration Solution 1 (944-135) Lot DV-02 is a solution used by the ABL 8x7 series creatine analyzers to establish calibration points for measured parameters.

    FDA Recall
    Terminated ·Radiometer America Inc·Product code CGL·December 16, 2011

    ABL90 FLEX analyzers with software versions 3.3MR1 or below. The ABL90 FLEX Analyzer is a portable, automated Analyzer that measures pH, blood gases, electrolytes, glucose, lactate, bilirubin and oximetry in whole blood. It is intended for use in a laboratory environment, near patient or point-of-care setting.

    FDA Recall
    Terminated ·Radiometer America Inc·Product code JJE·May 25, 2018

    AQURE basic sytem, FLEXLINK, REF 933-599, Version: 2.3.3 (17), CE IVD, Rx Only, UDI: (01)05700699335999 Intended use: The AQURE system is intended to let you manage analytical devices and operator profiles.

    FDA Recall
    Terminated ·Radiometer Medical ApS Akandevej 21 Bronshoj Denmark·Product code OUG·August 8, 2019

    Blood Gas and Co-Ox2 Electrolyte & Metabolyte Analyzers, ABL-700 Series, manufactured from 8/1998 through 11/2004.

    FDA Recall
    Terminated ·Radiometer America Inc·Product code JFP·September 29, 2005

    Capillary (end) caps, accessory for use with blood gas analyzers included in Radiometer''s CLINITUBES kits. The end caps are packaged in bags. These bags are placed in the capillary tube kit which also contains: capillary tubes, end caps, mixing wires, and a magnet. Each kit may contain 1 or 5 bags depending on the kit model. Each bag contains: 110 Green caps per bag and 160 Red caps per bag.

    FDA Recall
    Terminated ·Radiometer America Inc·Product code GIO·March 22, 2006

    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 Analyzer REF 393090 UDI:05700693930909

    FDA Recall
    Terminated ·Radiometer America Inc·Product code CEM·July 10, 2019

    Capillary (end) caps, accessory for use with blood gas analyzers included in Radiometer''s CLINITUBES kits. The end caps are packaged in bags. These bags are placed in the capillary tube kit which also contains: capillary tubes, end caps, mixing wires, and a magnet. Each kit may contain 1 or 5 bags depending on the kit model. Each bag contains: 110

    FDA Recall
    Terminated ·Radiometer America Inc·Product code GIO·March 22, 2006

    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

    TC Monitor - Transcutaneous Monitor for p02 and pC02, Model #TCM4, (Cutaneous Oxygen Monitor)

    FDA Recall
    Terminated ·Radiometer America Inc·Product code KLK·February 2, 2005

    TCM4 Series Monitoring System (Base Unit) 391-876 (affected device) CompactFlash cards: 914-698 (Defective Device Component)

    FDA Recall
    Terminated ·Radiometer America Inc·Product code KLK·April 7, 2006

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

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

    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

    The ABL800 Model#:All

    FDA Recall
    Terminated ·Radiometer America Inc·Product code CHL·January 26, 2017