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Vista de la lista Vista de las tarjetas
  • Dispositivo 84
  • Fabricante 28
  • Evento 124969
  • Implante 0
abx pentra 400, pentra c400
  • Modelo / Serial
  • Descripción del producto
    ivd
  • Manufacturer
    HORIBA ABXS
  • 1 Event
    • Notificaciones De Seguridad De Campo acerca de abx pentra 400, pentra c400
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 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 Diluent 20L Reagent
  • Modelo / Serial
  • Descripción del producto
    in-vitro_medical_device
  • Manufacturer
    Horiba ABX
  • 1 Event
    • Retiro De Equipo (Recall) de ABX Diluent 20L Reagent
Abx Eosinofix reagent
  • Modelo / Serial
  • Descripción del producto
    in-vitro_medical_device
  • Manufacturer
    Horiba ABX
  • 1 Event
    • Retiro De Equipo (Recall) de Abx Eosinofix reagent
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
  • 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 Uric Acid CPref. A11A01670
  • 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
    ABX PENTRA Uric Acid CP ref. A11A01670 is an in vitro diagnostic assay for the quantitative determination of uric acid in human serum, plasma and urine based on the enzymatic determination of uric acid using a chromogenic system in the presence of peroxidase and uricase (Trinder method).
  • Manufacturer
    Horiba Instruments Inc
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall ABX PENTRA Uric Acid CPref. A11A01670
Device Recall ABX PENTRA Triglycerides CPref. A11A01640
  • 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
    ABX PENTRA Triglycerides CP ref. A11A01640 is an in vitro diagnostic assay for the quantitative determination of triglycerides in human serum and plasma based on an enzymatic colorimetric test. It 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 Triglycerides CPref. A11A01640
Device Recall ABX PENTRA Lactic Acid CPref. A11A01721
  • 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
    ABX PENTRA Lactic Acid CP ref. A11A01721 || reagent is intended for the quantitative in vitro diagnostic determination of lactic acid in plasma by colorimetry. Lactic acid measurements that evaluate the acid-base status are used in the diagnosis and treatment of lactic acidosis (abnormally high acidity of the blood).
  • Manufacturer
    Horiba Instruments Inc
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall ABX PENTRA Lactic Acid CPref. A11A01721
Device Recall ABX PENTRA Glucose PAP CPref. A11A01668
  • Modelo / Serial
    All Lots
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    2
  • ¿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
    ABX PENTRA Glucose PAP CP ref. A11A01668 reagent is intended for the quantitative in vitro diagnostic determination of glucose in human serum, plasma and urine using glucose oxidase method by colorimetry.
  • Manufacturer
    Horiba Instruments Inc
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall ABX PENTRA Glucose PAP CPref. A11A01668
Device Recall ABX PENTRA Enzymatic Creatinine CPref. A11A01907
  • Modelo / Serial
    All Lots
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    2
  • ¿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
    ABX PENTRA Enzymatic Creatinine CP ref. A11A01907 reagent is intended for the quantitative in vitro diagnostic determination of creatinine in human serum, plasma and urine based on an enzymatic method of using a multi-step approach ending with a photometric end-point reaction.
  • Manufacturer
    Horiba Instruments Inc
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall ABX PENTRA Enzymatic Creatinine CPref. A11A01907
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
Device Recall Lite DM (Lite Data Manager)
  • Modelo / Serial
    Lot/Serial #(s): N/A Software Version(s): Versions 2.0.0.19 and lower. Expiration Date (s): N/A
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide within the U.S.
  • Descripción del producto
    Lite DM (Lite Data Manager) || Software Version(s): Versions 2.0.0.19 and lower || Product Model #: D00A00224D || The Lite DM (Lite Data Manager) is a software application developed by HORIBA || Medical intended to receive, store, and manage Startup, Patient, and Quality Control || (QC) results from an ABX Micros 60 Hematology Analyzer or ABX Micros CRP 200 || Hematology Analyzer. Only one instrument connection is allowed per each Lite DM || workstation. The Lite DM application runs on a PC within a Windows Operating || System platform. Data transmitted from the instrument to the Lite DM workstation is a Serial RS-232 unidirectional ABX Format communication. The Lite DM can act as a standalone data manager for data received from the instrument, or allow transmission of this data to a Host (LIS  Laboratory Information System or EMR  Electronic Medical Record system). || Following the completion of each blood sample analysis performed on the connected HORIBA Medical hematology analyzer, results are then communicated (uni-directional) to the Lite DM workstation. Results received will display to the user in a specific color coding format indicating any normal or panic reference range violations. Results are then rejected or accepted by the user for final reporting - formatted to guidelines stipulated by CLIA. At no time are any results interpreted; only reported for review and appropriate action.
  • Manufacturer
    Horiba Instruments Inc
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Lite DM (Lite Data Manager)
Device Recall The ABX PENTRA 400 / PENTRA C400 Reagent Container (15 mL)
  • Modelo / Serial
    DATE - MVT 25.08.2017
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide
  • Descripción del producto
    15 ML REAGENT CUP, B1037307, SAP 1221037307 for use with ABX PENTRA 400 / PENTRA C400
  • Manufacturer
    Horiba Instruments, Inc dba Horiba Medical
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall The ABX PENTRA 400 / PENTRA C400 Reagent Container (15 mL)
Device Recall The ABX PENTRA 400 / PENTRA C400 Reagent Container (10 mL)
  • Modelo / Serial
    DATE - MVT 25.08.2017
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide
  • Descripción del producto
    10 ML REAGENT CUP, B1034626, SAP 1221034626 for use with ABX PENTRA 400 / PENTRA C400
  • Manufacturer
    Horiba Instruments, Inc dba Horiba Medical
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall The ABX PENTRA 400 / PENTRA C400 Reagent Container (10 mL)
ABX Pentra 400 and ABX Pentra C400 analyzers
  • Modelo / Serial
  • Manufacturer
    Horiba ABX SAS
  • 1 Event
    • Retiro De Equipo O Alerta De Seguridad para ABX Pentra 400 and ABX Pentra C400 analyzers
ABX PENTRA CALCIO CP
  • Modelo / Serial
  • Manufacturer
    Horiba ABX SAS
  • 1 Event
    • Retiro De Equipo O Alerta De Seguridad para ABX PENTRA CALCIO CP
Validation and data management system ABX PENTRA ML, versions V8.0.X and earlier, and versions V9...
  • Modelo / Serial
  • Manufacturer
    Horiba ABX SAS
  • 1 Event
    • Retiro De Equipo O Alerta De Seguridad para Validation and data management system ABX PENTRA ML, versions V8.0.X and earlier, and versions V9.0.1 and V9.0.2
ABX Pentra 400 biochemistry analyzers (version 5.0.8 and lower) and Pentra C400 (version 1.1.2 an...
  • Modelo / Serial
  • Manufacturer
    HORIBA ABX SAS
  • 1 Event
    • Retiro De Equipo O Alerta De Seguridad para ABX Pentra 400 biochemistry analyzers (version 5.0.8 and lower) and Pentra C400 (version 1.1.2 and lower)
Validation and data management system ABX Pentra ML
  • Modelo / Serial
  • Manufacturer
    HORIBA ABX SAS
  • 1 Event
    • Retiro De Equipo O Alerta De Seguridad para Validation and data management system 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 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 Diluent 20L
  • 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 Diluent 20L
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
  • 1
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