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  • 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 difftrol control material, flight px413h, used in the pentra 60, pentra 80 and pentra 120 ana...
  • Modelo / Serial
  • Manufacturer
    HORIBA Medical
  • 1 Event
    • Notificaciones De Seguridad De Campo acerca de abx difftrol control material, flight px413h, used in the pentra 60, pentra 80 and pentra 120 analyzers
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
abx difftrol control blood, px403 flight, used in the pentra 120, pentra dx / df and nexus analyzers
  • Modelo / Serial
  • Manufacturer
    Horiba Medical
  • 1 Event
    • Notificaciones De Seguridad De Campo acerca de abx difftrol control blood, px403 flight, used in the pentra 120, pentra dx / df and nexus analyzers
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
Yumizen H500 CT (Closed Tube)
  • Modelo / Serial
  • Manufacturer
    HORIBA ABX SAS
  • 1 Event
    • Notificaciones De Seguridad De Campo acerca de Yumizen H500 CT (Closed Tube)
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
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 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 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 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 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
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 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
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)
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 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 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 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
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