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  • Dispositivo 84
  • Fabricante 28
  • Evento 124969
  • Implante 0
ABX Pentra Calcium CP
  • Modelo / Serial
    A11A01633 | 14664503
  • Descripción del producto
    IVD: Calcium kit
  • Manufacturer
    Horiba ABX
  • 1 Event
    • Notificaciones De Seguridad De Campo acerca de ABX Pentra Calcium CP
ABX Pentra Calcium CP
  • Modelo / Serial
  • Descripción del producto
    In-vitro diagnostics - equipment / products for clinical chemistry
  • Manufacturer
    Horiba
  • 1 Event
    • Notificaciones De Seguridad De Campo acerca de ABX Pentra Calcium CP
ABX PENTRA CALCIUM CP
  • Modelo / Serial
  • Descripción del producto
    In-vitro diagnostic products
  • Manufacturer
    HORIBA ABX SAS
  • 1 Event
    • Notificaciones De Seguridad De Campo acerca de ABX PENTRA CALCIUM CP
ABX PENTRA Calcium CP Reagent
  • Modelo / Serial
  • Descripción del producto
    in-vitro_medical_device
  • Manufacturer
    Horiba ABX
  • 1 Event
    • Retiro De Equipo (Recall) de ABX PENTRA Calcium CP Reagent
ABX PENTRA Calcium CP Reagent, Model A11A01633
  • Modelo / Serial
    Lot/Serial #(s): 014664503
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA including the country of Canada.
  • Descripción del producto
    ABX PENTRA Calcium CP Reagent, Model # A11A01633 || Calcium plays an essential role in many cell functions: intracellularly in muscle contraction and glycogen metabolism, extracellularly, in bone mineralization, in blood coagulation and in transmission of nerve impulses. Calcium is present in plasma in three forms: free, bound to proteins or complexed with anions as phosphate, citrate and bicarbonate. Under physiological conditions, calcium balance is determined by the relationship between calcium intake and calcium absorption and excretion. Urinary excretion is an important determinant of calcium retention in the body. Decreased total calcium levels can be associated with diseases of the bone apparatus (especially osteoporosis), kidney diseases (especially under dialysis), defective intestinal absorption and hypoparathyroidism. Increased total calcium can be measured in hyperparathyroidism, malignant diseases with metastases and sarcoidosis. Calcium measurements also help in monitoring of calcium supplementation mainly in the prevention of osteoporosis.
  • Manufacturer
    Horiba Instruments, Inc dba Horiba Medical
  • 1 Event
    • Retiro De Equipo (Recall) de ABX PENTRA Calcium CP Reagent, Model A11A01633
ABX PENTRA Creatinine 120 CP
  • Modelo / Serial
    Model Number Creatinine Part # A11A01868, Lot Numbers: 203273706, 203273707, 203273808, 203273709.
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution
  • Descripción del producto
    ABX PENTRA Creatinine 120 CP, Model Number Creatinine Part # A11A01868, Lot Numbers: 203273706, 203273707, 203273808, 203273709. || The ABX PENTRA Creatinine 120 CP is an in vitro diagnostic assay for the quantitative determination of creatinine in human serum, plasma and urine based on a kinetic method using alkaline picrate (Jaffe method). It is composed of a 27 ml monoreagent cassette. Reagent is a chemical solution with additives. || ABX PENTRA Creatinine 120 CP reagent, with associated calibrator and controls, is a diagnostic reagent for quantitative in vitro determination of Creatinine in human serum, plasma and urine based on a kinetic method using alkaline picrate (Jaffe method). Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes. This reagent is intended for use on the ABX PENTRA 400 Clinical Chemistry Analyzer.
  • Manufacturer
    Horiba Instruments, Inc dba Horiba Medical
  • 1 Event
    • Retiro De Equipo (Recall) de ABX PENTRA Creatinine 120 CP
ABX PENTRA HbA1c WB Cal
  • Modelo / Serial
    A11A01703 | 1704201 and after
  • Descripción del producto
    IVD: Multicomponent clinical chemistry calibrator
  • Manufacturer
    Horiba ABX
  • 1 Event
    • Notificaciones De Seguridad De Campo acerca de ABX PENTRA HbA1c WB Cal
ABX PENTRA HbA1c WB Cal
  • Modelo / Serial
  • Manufacturer
    HORIBA ABX
  • 1 Event
    • Notificaciones De Seguridad De Campo acerca de ABX PENTRA HbA1c WB Cal
ABX PENTRA Magnesium RTU
  • Modelo / Serial
    All Lots
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    US Nationwide Distribution.
  • Descripción del producto
    ABX PENTRA Magnesium RTU Reagent, Part No. A11A01646 || Product Usage: ABX PENTRA Magnesium RTU reagent with associated calibrators and controls are for quantitative in vitro diagnostic determination of magnesium in human serum and plasma based on a photometric test using xylidyl blue. Magnesium measurements are used in the diagnosis and treatment of hypomagnesemnia (abnormally low plasma levels of magnesium) and hypermagnesemnia (abnormally high plasma levels of magnesium).
  • Manufacturer
    Horiba Instruments, Inc dba Horiba Medical
  • 1 Event
    • Retiro De Equipo (Recall) de ABX PENTRA Magnesium RTU
ABX Pentra Micro ALBUMIN 2 CP
  • Modelo / Serial
    All lot numbers; Software Version(s): Application versions below (V5.14 & V2.12) for Pentra 400 and Versions below (V1.07) for Pentra C400
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution: US (nationwide) and to countries of: Bulgaria, Burma, Cameroon, Djibouti, France, Gabon, Germany, Italy, Lebanon, Mali, Mauritania, Poland, Portugal, Romania, Saudi Arabia, South Africa and Thailand.
  • Descripción del producto
    ABX Pentra Micro ALBUMIN 2 CP, Serum/Plasma, REF 1300032563 || The device is intended for use in conjunction with certain materials to measure a variety of analytes.
  • Manufacturer
    Horiba Instruments, Inc dba Horiba Medical
  • 1 Event
    • Retiro De Equipo (Recall) de ABX Pentra Micro ALBUMIN 2 CP
abx pentra ml
  • Modelo / Serial
  • Descripción del producto
    ivd
  • Manufacturer
    HORIBA ABXS
  • 1 Event
    • Notificaciones De Seguridad De Campo acerca de abx pentra ml
ABX Pentra ML
  • Modelo / Serial
  • Descripción del producto
    In-vitro diagnostics - haematological, histological and cytological products
  • Manufacturer
    Horiba ABX
  • 1 Event
    • Notificaciones De Seguridad De Campo acerca de ABX Pentra ML
ABX Pentra ML
  • Modelo / Serial
    Lot/Serial# PML0937
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide in the US, including the states of CA, MI, IN, FL, and GA. Center Recall Depth is Retail.
  • Descripción del producto
    ABX PENTRA ML, Software Versions: V8.0.x and Below; V.9.0.1 and V9.0.2
  • Manufacturer
    Horiba Instruments, Inc dba Horiba Medical
  • 1 Event
    • Retiro De Equipo (Recall) de ABX Pentra ML
ABX PENTRA ML
  • Modelo / Serial
  • Descripción del producto
    In-vitro diagnostics - haematological, histological and cytological products
  • Manufacturer
    HORIBA
  • 1 Event
    • Notificaciones De Seguridad De Campo acerca de ABX PENTRA ML
ABX PENTRA ML
  • Modelo / Serial
    all
  • Descripción del producto
    IVD: Data management system
  • Manufacturer
    Horiba ABX
  • 1 Event
    • Notificaciones De Seguridad De Campo acerca de ABX PENTRA ML
ABX PENTRA ML
  • Modelo / Serial
    V8.0.x and below, V9.0.1 and V9.0.2
  • Descripción del producto
    IVD: Data management system
  • Manufacturer
    Horiba ABX
  • 1 Event
    • Notificaciones De Seguridad De Campo acerca de ABX PENTRA ML
ABX PENTRA ML
  • Modelo / Serial
  • Descripción del producto
    ABX PENTRA ML
  • Manufacturer
    Horiba Medical
  • 1 Event
    • Notificaciones De Seguridad De Campo acerca de ABX PENTRA ML
ABX PENTRA ML
  • Modelo / Serial
  • Manufacturer
    HORIBA ABX SAS
  • 1 Event
    • Notificaciones De Seguridad De Campo acerca de ABX PENTRA ML
abx pentra ml versions v8.0.x and under, versions v9.0.1 and v9.0.2
  • Modelo / Serial
  • Manufacturer
    HORIBA Medical
  • 1 Event
    • Notificaciones De Seguridad De Campo acerca de abx pentra ml versions v8.0.x and under, versions v9.0.1 and v9.0.2
abx pentra p control target values ​​for the cholesterol parameter on the pentra c200, pentra 400...
  • Modelo / Serial
  • Manufacturer
    Horiba Medical
  • 1 Event
    • Notificaciones De Seguridad De Campo acerca de abx pentra p control target values ​​for the cholesterol parameter on the pentra c200, pentra 400 and pentra c400
Device Recall ABX Micros IM2
  • Modelo / Serial
    All serial numbers
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution
  • Descripción del producto
    ABX Micros IM2, Part# M60CSB110EN04 and D00A00202 || The IM2 Data Management System consists of the IM2 Data Manager Software, Desktop Computer, keyboard, mouse, and a unidirectional serial cable. The IM2 software is used to store, retrieve, and process laboratory data received via a unidirectional serial connection from the ABX Micros 60.
  • Manufacturer
    Horiba Instruments, Inc dba Horiba Medical
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall ABX Micros IM2
Device Recall ABX Pentra 400
  • Modelo / Serial
    All lot/serial #s
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    USA (nationwide Distribution) to the states of : CA, NY, AL,OK, MS, MD, NV, MN, TX, KY, WV, MI, NY, MT, IL, FL,WA, ID, MO, WY, NJ, VA, KY, GA, PA, TN, MS, KS, AZ, NE, SC, OR, OH, IA, RI, MI and NC.
  • Descripción del producto
    ABX Pentra 400 (version 5.0.8 or lower) || The ABX PENTRA 400 and 400C are discrete photometric bench top chemistry analyzers for clinical use. The device is intended to duplicate manual analytical procedures by performing various steps such as pipetting, mixing, heating and measuring color intensity. The device is intended for use in conjunction with certain materials to measure a variety of analytes.
  • Manufacturer
    Horiba Instruments Inc
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall ABX Pentra 400
Device Recall ABX PENTRA 400C
  • Modelo / Serial
    All lot/serial #s
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    USA (nationwide Distribution) to the states of : CA, NY, AL,OK, MS, MD, NV, MN, TX, KY, WV, MI, NY, MT, IL, FL,WA, ID, MO, WY, NJ, VA, KY, GA, PA, TN, MS, KS, AZ, NE, SC, OR, OH, IA, RI, MI and NC.
  • Descripción del producto
    Pentra C400 (version 1.1.2 or lower) || The ABX PENTRA 400 and 400C are discrete photometric bench top chemistry analyzers for clinical use. The device is intended to duplicate manual analytical procedures by performing various steps such as pipetting, mixing, heating and measuring color intensity. The device is intended for use in conjunction with certain materials to measure a variety of analytes.
  • Manufacturer
    Horiba Instruments Inc
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall ABX PENTRA 400C
Device Recall ABX PENTRA 400 I.S.E. Module
  • Modelo / Serial
    Model Numbers: P400ISE110EN02 and P400ISE110US02. All Serial Numbers. Versions 5.0.7 and below
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution.
  • Descripción del producto
    HORIBA ABX PENTRA 400 I.S.E. Module, Model Numbers: P400ISE110EN02 and P400ISE110US02, All Serial Numbers, Software Versions 5.0.7 and Below. || Used to measure absorbance and ion electrodes.
  • Manufacturer
    Horiba Instruments, Inc dba Horiba Medical
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall ABX PENTRA 400 I.S.E. Module
Device Recall ABX PENTRA Cholesterol CPref. A11A01634
  • Modelo / Serial
    All Lots
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    U.S. distribution to the following; CA, NY, AL, OK, MN, MS, MD, TX, KY, WV, MT, IL, FL, VA, WA, MI, KS, NE, PA, OH, ID, OR, AR, AZ, NM, NC, SC, GA, TN No foreign distribution.
  • Descripción del producto
    The ABX PENTRA Cholesterol CP ref. A11A01634 is an in vitro diagnostic assay for quantitative determination of cholesterol in human serum and plasma based on an enzymatic photometric test (Trinders reaction). The assay is composed of a 99 ml mono-reagent cassette. Reagent is a chemical solution with additives.
  • Manufacturer
    Horiba Instruments Inc
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall ABX PENTRA Cholesterol CPref. A11A01634
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