BEUDAMED
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    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

    LifeScan brand One Touch -Sure Step Pro- Blood Glucose Monitoring System Test Strips, 50 strips per package, Distributed and Manufactured by: LifeScan, Inc., 1000 Gibraltar Drive, Milpitas, CA 95037

    FDA Recall
    Terminated ·Lifescan Inc·Product code CGA·September 29, 2006

    Glucose Hexokinase Liquid Reagent For the in vitro quantitative determination of Glucose in serum.

    FDA Recall
    Terminated ·JAS Diagnostics Inc.·Product code CGA·April 7, 2014

    arkray SPOTCHEM II Glucose Reagent test strips, Item No. 77101, MEDTEST DX Catalog # 77424. For the in vitro quantitative determination of glucose in human plasma from whole blood samples.

    FDA Recall
    Terminated ·Arkray Factory USA, Inc.·Product code CGA·December 18, 2015

    HemoCue Glucose 201 Microcuvettes, The HemoCue Glucose 201 Microcuvettes are designed for use with the HemoCue Glucose 201Analyzer and the HemoCue Glucose 201 DM Analyzer (hereafter referred to as the HemoCue Glucose 201 Analyzer). HemoCue Glucose 201 Microcuvettes are available in individual packages or in vials. Affected lots identified initially were 110705, 110706, 110715, 110716, 110717, 110718, 110719, and 110720. Subsequent investigation also identified as affected lots 1310227, 1310252, and 1310257. HemoCue Glucose 201 Microcuvettes, The HemoCue Glucose 201 Microcuvettes are designed for use with the HemoCue Glucose 201Analyzer and the HemoCue Glucose 201 DM Analyzer (hereafter referred to as the HemoCue Glucose 201 Analyzer). HemoCue Glucose 201 Microcuvettes are available in individual packages or in vials.

    FDA Recall
    Terminated ·Radiometer America Inc·Product code CGA·October 20, 2014

    ADVIA CHEMISTRY GLUCOSE OXIDASE ASSAY AND ADVIA Chemistry Glucose & Concentrated Glucose Oxidase Assay and ADVIA Chemistry Glucose.

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code CGA·March 17, 2016

    CHOL+HDL+GLU test strips, REF 2412

    FDA Recall
    Terminated ·Polymer Technology Systems, Inc.·Product code CGA·January 16, 2019

    RX Monaco-IVD Clinical Chemistry Analyser Catalog Number: RX5000

    FDA Recall
    Open, Classified ·Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland·Product code CGA·September 6, 2023

    VITROS Chemistry Products GLU Slides, REF/Product Code 170 7801 (300 slides per sales unit), Unique Device Identifier No. 10758750009572, Rx ONLY, IVD --- For in vitro diagnostic use only. VITROS Chemistry Products 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·August 11, 2016

    Abbott Cholestech LDX Battery Kit, Model: 3LP656194-PCM-LD, PN: 55170

    FDA Recall
    Open, Classified ·Alere San Diego, Inc.·Product code CGA·March 1, 2024

    Glucose Oxidase Reagent as follows: Pointe Scientific Glucose Oxidase Reagent Set, Pointe Scientific, Inc, Canton, MI; Catalog # G7519-1L, G7519-500 and G7519-SAM. 2MM Diagnostics Glucose Oxidase Reagent Set, 2MM Corporation, Miami, FL; Reorder # RT-160-500. Pointe Scientific Glucose Oxidase Reagent, Pointe Scientific, Inc., Canton, MI; Catalog, MI; Catalog # 2-G7519-L, 7-G7519-100, 7-G7519-200, 7-G7519-1000, 8-G7519-100, and 12-RT-160-500. For the quantitative determination of Glucose in human serum. For in vitro diagnostic use only.

    FDA Recall
    Terminated ·Pointe Scientific, Inc.·Product code CGA·November 3, 2008

    Envoy 500 system includes the following product reference numbers and names: 55345 ENVOY 500 Glucose 55450 ENVOY 500 URIC ACID REAGENT KIT 55435 ENVOY 500 TRIGLYCERIDES REAGENT KIT, 55297 ENVOY 500 CHOLESTEROL REAGENT KIT, 55335 ENVOY 500 CREATININE REAGENT KIT 55301 ENVOY 500 HDL CHOLESTEROL REAGENT 55310 ENVOY 500 LDL CHOLESTEROL REAGENT KIT

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

    Sterling Diagnostics, Inc., Enzymatic Glucose for IN VITRO DIAGNOSTIC USE in the quantitative determination of analytes. These are CONSUMABLES - a customer buys another when kit is consumed.

    FDA Recall
    Terminated ·Sterling Diagnostics, Inc.·Product code CGA·July 20, 2016

    Hypoguard Advance Micro-draw Blood Glucose Monitoring System, Product Number : 411100, For In Vitro Diagnostic Use, Manufactured for ARKRAY USA, Inc., Minneapolis, MN 55439 USA. (Package Contents -Advance Micro-draw Blood Glucose Meter, 10 test Strips, Codeing chip and Control Solution (3mL), Lancing device, 10 Lancets, 3V Lithium Battery, Logbook, User Instruction Manual, Quick Reference Guide)

    FDA Recall
    Terminated ·ARKRAY USA INC.·Product code CGA·October 18, 2007