Device Recall ABX Pentra 400

  • Modelo / Serial
    All lot/serial #s
  • Clasificación del producto
  • 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
  • 1 Event

Fabricante

  • Dirección del fabricante
    Horiba Instruments Inc, 9755 Research Dr, Irvine CA 92618-4626
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA

2 dispositivos con un nombre similar

Más información acerca de la data acá

  • Modelo / Serial
    All lot/serial #s
  • Clasificación del producto
  • 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
  • Modelo / Serial
    Model Numbers: P400ISE110EN02 and P400ISE110US02. All Serial Numbers. Versions 5.0.7 and below
  • Clasificación del producto
  • 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