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    Vitros Chemistry *** GLU (glucose) Slides *** 5 cartridges each containing 60 slides for a total of 300 tests per box *** REF 170 7801 *** Ortho-Clinical Diagnostics Inc., 100 Indigo Creek Drive, Rochester, NY 14626. [NOTE: product has an 18 month shelf life.]

    FDA Recall
    Terminated ·Ortho-Clinical Diagnostics·Product code CGA·July 28, 2003

    Nova StatStrip/StatSensor Hospital Blood Glucose Meter; Nova StatStrip Lactate Hospital Meter System; Nova StatSensor Creatinine Hospital Meter, Rechargeable Lithium Batteries Single: 46626; 4 Pack: 46827; 5 Pack: 50436. For Point-Of-Care usage in the quantitative determination of Glucose in whole blood.

    FDA Recall
    Terminated ·Nova Biomedical Corporation·Product code CGA·October 10, 2013

    Roche brand AccuData GTS Plus System; Catalog number 3000249, material number 03000249001.

    FDA Recall
    Terminated ·Roche Diagnostics Corp.·Product code CGA·April 18, 2005

    OneTouchBasic/Profile and OneTouch Ultra- Blood Glucose test strips. For use with ONE TOUCH Brand Meters.

    FDA Recall
    Terminated ·Milwaukee Notions, Inc·Product code CGA·October 10, 2006

    LifeScan OneTouch Ultra Test strips, lot number 2528640

    FDA Recall
    Terminated ·Lifescan Inc·Product code CGA·November 1, 2005

    ACCU-CHEK Advantage Blood Glucose Meter/ Blood Glucose Monitoring System; Cat. no. 870. Ref. no. 080087000 with meter model number 870; Ref. no.0353756001 with meter model number 33304510; Ref. no. 03537536001 with meter model no. 2138930; Ref. no. 03537536001 with meter model no. 3288650.

    FDA Recall
    Terminated ·Roche Diagnostics Corp.·Product code CGA·June 22, 2006

    ACCU-CHEK Advantage (Managed Care Kit) 100- value memory with time and date, Not for Retail Sale, Cat. No. 3000389; Ref no. 03000389001 with meter model no. 2138930.

    FDA Recall
    Terminated ·Roche Diagnostics Corp.·Product code CGA·June 22, 2006

    Instrumentation Laboratory GEM Premier 4000 PN 00025000000 The GEM Premier 4000 is a portable critical care system for use by health care professionals to rapidly analyze whole blood samples at the point of health care delivery in a clinical setting and in a central laboratory. The instrument provides quantitative measurements of pH, pC02, p02, sodium, potassium, chloride, ionized calcium, glucose, lactate, hematocrit, total bilirubin and CO-OXimetry (tHb, 02Hb, COHb, MetHb, HHb) parameters. Total bilirubin can also be quantitated from heparinized plasma samples when analyzed in the tBili/CO-Ox mode. These parameters, along with derived parameters, aid in the diagnosis of a patient's acidlbase status, electrolyte and metabolite balance and oxygen delivery capacity. Total bilirubin measurements are used in the diagnosis and management of biliary tract obstructions, liver disease and various hemolytic diseases and disorders involving the metabolism of bilirubin. In neonates, the level of total bilirubin is used to aid in assessing the risk of kernicterus

    FDA Recall
    Terminated ·Instrumentation Laboratory Co.·Product code CGA·February 14, 2011

    VITROS Chemistry Products GLU Slides packaged as 300 slides/pack catalog number 1707801 VITROS GLU Slides quantitatively measure glucose (GLU) concentration in serum, plasma, urine and cerebrospinal fluid using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.

    FDA Recall
    Terminated ·Ortho-Clinical Diagnostics·Product code CGA·June 12, 2013

    ELITech Clinical Systems reagents used on the Selectra ProS and ProM systems that utilize the Trinder Reaction method. The following product reference numbers and names: GPSL-025O: Glucose PAP SL AUML-0250: URIC ACID MONO SL CHSL-0250: CHOLESTEROL SL, TGML-0250: TRIGLYCERIDES SL, CRSL-0250: CREATININE PAP SL HDLL-0230: CHOLESTEROL HDL SL 2G LDLL-0230: CHOLESTEROL LDL SL 2G

    FDA Recall
    Terminated ·ELITech Clinical Systems SAS Zone lndustrielle SEES France·Product code CGA·September 22, 2015

    Eon 100 system included the following product reference numbers and names: Reference no. 77345- Glucose (GPSL) Reference no. 77450- Uric acid (AUVD) Reference no. 77435- Triglycerides (TGML) Reference no. 77295- Cholesterol (CHVD) Reference no. 77301- Cholesterol HDL (HDLL) Reference no. 77310- Cholesterol, LDL (LDLL)

    FDA Recall
    Terminated ·ELITech Clinical Systems SAS Zone lndustrielle SEES France·Product code CGA·September 22, 2015

    Nova StatStrip Xpress Glu-Test Strips (Glucose test strips) Catalog # 51493 (UK Only)

    FDA Recall
    Terminated ·Nova Biomedical Corporation·Product code CGA·February 25, 2013

    ACCU-CHEK Advantage (Conversion Kit),Cat. no. 3000338; Ref no. 03000338001 with meter model no. 2138930.

    FDA Recall
    Terminated ·Roche Diagnostics Corp.·Product code CGA·June 22, 2006

    Roche brand Omni S4 Blood Gas Analyzer; Catalog # 03337138001.

    FDA Recall
    Terminated ·Roche Diagnostics Corp.·Product code CGA·December 9, 2005

    Martel Printer The Martel Printer is an accessory to the i-STAT Portable clinical Analyzer (model 300). The i-STAT Analyzer is used by trained medical professionals for running a variety of clinical chemistry tests and test panels contained in i-STAT test cartridges. These tests include Hematocrit, glucose, blood urea nitrogen, sodium, potassium, chloride, ionized calcium, blood gases (oxygen, carbon dioxide, and pH), Creatinine, lactate and activated clotting time.

    FDA Recall
    Terminated ·Abbott Point of Care Inc.·Product code CGA·November 6, 2009

    GLUCm used on Synchron LX and UniCel DxC Synchron Clinical Systems, Part Number: 472500 ( ynchron LX20, LX20 PRO, LXI 725, UniCel DxC 600, UniCel DxC 600 PRO, UniCel DxC 600i, UniCel DxC 800, UniCel DxC 800 PRO, UniCel DxC 880i, UniCel DxC 680i, UniCel DxC 660i, and UniCel DxC860i ),

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code CGA·April 15, 2010

    Roche brand AccuData GTS System; Catalog number 404, material number 03136833001.

    FDA Recall
    Terminated ·Roche Diagnostics Corp.·Product code CGA·April 18, 2005

    i-STAT 1 Analyzer, Abbott Point of Care Inc., Abbott Park, IL 60064 USA, Product of USA. The product is intended to be used by trained medical professionals for use with i-STAT test cartridges and MediSense blood glucose test strips. i-STAT cartridges comprise a variety of clinical chemistry tests and test panels.

    FDA Recall
    Terminated ·Abbott Point of Care Inc.·Product code CGA·September 9, 2009

    Vitros Chemistry *** GLU (glucose) DT Slides ***25 slides per box *** CAT 153 2316 *** Ortho-Clinical Diagnostics Inc. , 100 Indigo Creek Dr., Rochester, NY 14626. [NOTE: product has a 24-month shelf life.]

    FDA Recall
    Terminated ·Ortho-Clinical Diagnostics·Product code CGA·July 28, 2003

    ACCU-CHEK Instant Meter; Catalog numbers 914 and 924.

    FDA Recall
    Terminated ·Roche Diagnostics Corp.·Product code CGA·May 18, 2005