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  • Dispositivo 84
  • Fabricante 28
  • Evento 124969
  • Implante 0
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 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 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 ML
  • Modelo / Serial
    Model/Part #(s): A11A01652 Lot/Serial #(s): N/A Software Version(s): All versions are subject to this correction. Shelf Life: N/A
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    USA Nationwide Distribution
  • Descripción del producto
    Device Name: ABX PENTRA ML || Model/Part #(s): A11A01652 || Lot/Serial #(s): N/A || Software Version(s): All versions are subject to this correction. || Product Usage: || The ABX PENTRA ML is a software data management system intended for use on ABX Hematology Analyzers.
  • Manufacturer
    Horiba Instruments, Inc dba Horiba Medical
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall ABX PENTRA ML
Device Recall ABX PENTRA Multical. ABX PENTRA N Control ABX PENTRA P Control
  • Modelo / Serial
    Model Numbers:Multical - A11A01652, N Control - A11A01653, P Control - A11A01654.  Lot Numbers: MultiCal: 1204101 and 1304901, N Control: 1300801, P Control: 1300601.  Expiration Date (s): MultiCal: 1204101 Expires on 05/31/14, MultiCal: 1304901 Expires on 07/15/15, N Control: 1300801 Expires on 11/05/14, P Control: 1300601 Expires on 11/05/14.
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    United States nationwide distribution.
  • Descripción del producto
    ABX PENTRA Multical. || ABX PENTRA N Control. || ABX PENTRA P Control. || The ABX PENTRA 400 and PC200 are benchtop clinical chemistry analyzers using two || measuring principals: absorbance and ion selective electrodes. || The ABX PENTRA Multical is a lyophilized human serum calibrator with chemical || additives and materials of biological origin. The assigned values of the calibrator || components are given in the enclosed annex, ensuring optimal calibration of the || appropriate HORIBA ABX SAS methods on the ABX PENTRA Clinical Chemistry || Analyzer. This calibrator is provided in ten vials of 3 ml.
  • Manufacturer
    Horiba Instruments, Inc dba Horiba Medical
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall ABX PENTRA Multical. ABX PENTRA N Control ABX PENTRA P Control
Device Recall ABX PENTRA N Control,
  • Modelo / Serial
    Lot No. 1300801
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA (nationwide)
  • Descripción del producto
    ABX PENTRA N Control, Model No. A11A01653 || The ABX PENTRA N Control is for use in quality control by monitoring accuracy and precision for the quantitative methods as specified in the enclosed annex.
  • Manufacturer
    Horiba Instruments, Inc dba Horiba Medical
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall ABX PENTRA N Control,
Device Recall ABX PENTRA Reagent Container
  • Modelo / Serial
    Model No. B1037307 (15 mL), B1034626 (10 mL), and B1034634 (4 mL) manufactured since June 2014.
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide in US
  • Descripción del producto
    ABX PENTRA Reagent Container, Model No. B1037307 (15 mL), B1034626 (10 mL), and B1034634 (4 mL)
  • Manufacturer
    Horiba Instruments, Inc dba Horiba Medical
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall ABX PENTRA Reagent Container
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 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 Urine Control L/H
  • Modelo / Serial
    Model/Part #(s): A11A01674. Lot/Serial #(s): 1207001, 1303601, and 1300701. Shelf Life: Lot#s 1207001 & 1300701 Expire on: 06/30/2014. Lot# 1303601 Expires on: 09/30/2014.
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA (nationwide) and Canada.
  • Descripción del producto
    ABX PENTRA Urine Control L/H. || The ABX PENTRA Urine Control L/H is a two-level (Low and High) quality control || consisting of liquid solutions prepared from human urine with chemical additives and || materials of biological origin added as required to obtain given component levels. The || assigned values of the control components are given in the labeling, ensuring control of || the appropriate HORIBA ABX SAS methods on the ABX PENTRA chemistry analyzers. || Each control level is provided in one vial of 10 ml. || The ABX PENTRA Urine Control L/H is for use in quality control by monitoring accuracy and precision.
  • Manufacturer
    Horiba Instruments, Inc dba Horiba Medical
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall ABX PENTRA Urine Control L/H
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 (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)
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)
Eosinofix
  • Modelo / Serial
  • Descripción del producto
    Eosinofix
  • Manufacturer
    Horiba ABX SAS
  • 1 Event
    • Notificaciones De Seguridad De Campo acerca de Eosinofix
HBA1C, A1c_H, A1c_WB
  • Modelo / Serial
  • Descripción del producto
    In-vitro diagnostics - equipment / products for clinical chemistry
  • Manufacturer
    HORIBA ABX SAS
  • 1 Event
    • Notificaciones De Seguridad De Campo acerca de HBA1C, A1c_H, A1c_WB
HORIBA ABX
  • Modelo / Serial
  • Descripción del producto
    Horiba Medical: HORIBA ABX
  • Manufacturer
    Horiba Medical
  • 2 Events
    • Alerta De Seguridad O Notificaciones De Seguridad para HORIBA ABX
    • Alerta De Seguridad O Notificaciones De Seguridad para HORIBA ABX
markings abx pentra lipase cp reagent on the abx pentra 400 / pentra c400 analyzers
  • Modelo / Serial
  • Manufacturer
    HORIBA Medical
  • 1 Event
    • Notificaciones De Seguridad De Campo acerca de markings abx pentra lipase cp reagent on the abx pentra 400 / pentra c400 analyzers
Minotrol 16
  • Modelo / Serial
    Model Numbers: 2043748, 2043752, 2043756, Lot Number: MX090(Levels Low, Normal, and High).
  • Clasificación del producto
    Hematology and Pathology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution
  • Descripción del producto
    Minotrol 16, Model Numbers: 2043748, 2043752, 2043756, Lot Number: MX090(Levels: Low, Normal, and High). || Minotrol 16 is a tri-level control intended for in vitro diagnostic use in monitoring the accuracy and precision on HORIBA Medical hematology blood cell counters using HORIBA Medical reagents. Minotrol 16 is an in vitro diagnostic reagent composed of human erythrocytes, mammalian leukocytes, and platelets in a plasma-like fluid with preservatives. Minotrol 16 is a stable material that provides a means of determining the accuracy and precision of hematology blood cell counters. It is handled in the same manner as a patient specimen. The assay tables are determined on validated instruments using the appropriate reagents
  • Manufacturer
    Horiba Instruments, Inc dba Horiba Medical
  • 1 Event
    • Retiro De Equipo (Recall) de Minotrol 16
Pentra 120
  • Modelo / Serial
    Pentra 120 | all
  • Descripción del producto
    IVD: 5 part differential low/medium end blood cell counter
  • Manufacturer
    Horiba ABX
  • 1 Event
    • Notificaciones De Seguridad De Campo acerca de Pentra 120
Pentra 120 retic
  • Modelo / Serial
    Pentra 120 retic | all
  • Descripción del producto
    IVD: 5 part differential low/medium end blood cell counter
  • Manufacturer
    Horiba ABX
  • 1 Event
    • Notificaciones De Seguridad De Campo acerca de Pentra 120 retic
PENTRA 400 Software
  • Modelo / Serial
  • Descripción del producto
    In-vitro diagnostics
  • Manufacturer
    Horiba Medical
  • 1 Event
    • Notificaciones De Seguridad De Campo acerca de PENTRA 400 Software
PENTRA C200
  • Modelo / Serial
    Lot number: 00456-4108
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution including CA, OK, NY, FL, AZ, NY, VA, and TX.
  • Descripción del producto
    PENTRA C200, Part Number: A11A01629. || The Pentra C200 system is a fully automated chemistry analyzer using colorimetry, turbidmetry and potentiometry technologies. It is mostly dedicated to in vitro diagnostic analyses based on homogeneous samples such as serum, plasma and uring.
  • Manufacturer
    Horiba Instruments, Inc dba Horiba Medical
  • 1 Event
    • Retiro De Equipo (Recall) de PENTRA C200
Pentra C400
  • Modelo / Serial
    1.1.2 or lower
  • Descripción del producto
    IVD: Clinical chemistry analyser
  • Manufacturer
    Horiba ABX
  • 1 Event
    • Notificaciones De Seguridad De Campo acerca de Pentra C400
Pentra C400
  • Modelo / Serial
    Reagent containers: B1034626 (1221034626) and B1037307 (1221037307)
  • Descripción del producto
    IVD: Clinical chemistry analyser
  • Manufacturer
    Horiba ABX SAS
  • 1 Event
    • Notificaciones De Seguridad De Campo acerca de Pentra C400
Pentra DF 120
  • Modelo / Serial
    Pentra DF 120 | all
  • Descripción del producto
    IVD: 5 part differential low/medium end blood cell counter
  • Manufacturer
    Horiba ABX
  • 1 Event
    • Notificaciones De Seguridad De Campo acerca de Pentra DF 120
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