Device Recall Dimension Integrated Chemistry Systems

  • Modelo / Serial
    Dimension EXL with LM STM Catalog Numbers 778031.911 (Domestic) /778031.931 (Intl). All serial numbers.
  • Clasificación del producto
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    US Nationwide Distribution: FL, NY, SC, TX, LA, AZ, WI, IA, IL, OH, AL, AK, NH, OK, MD, CA, NM, MS, KY, NJ, MN, GA, CO, MA, SD, TN, MO, PA, MT, SC, NE, KS, VA, AL, NV, WY, OR, PR, MO, OK, GU, HI, AR, ME, VT, CT, NC and the countries of Canada and Mexico.
  • Descripción del producto
    Reagent Management System (RMS) || Dimension EXL with LM STM || Product Usage: || The Reagent Management System (RMS) is a module for use with the Dimension¿ clinical chemistry system. The RMS doubles the available storage of refrigerated Flex¿ reagent cartridges on the Dimension¿ system from 44 to 88. The RMS loads, hydrates, and automatically removes Flex¿ reagent cartridges, allowing the Dimension¿ system to process samples without interruption.
  • Manufacturer
  • 1 Event

Fabricante

  • Dirección del fabricante
    Siemens Healthcare Diagnostics Inc., 101 Silvermine Rd, Brookfield CT 06804-2047
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA

4 dispositivos con un nombre similar

Más información acerca de la data acá

  • Modelo / Serial
    Dimension EXL with LM Catalog Numbers 778021.911 (Domestic)/ 778021.931 (Intl). All serial numbers.
  • Clasificación del producto
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    US Nationwide Distribution: FL, NY, SC, TX, LA, AZ, WI, IA, IL, OH, AL, AK, NH, OK, MD, CA, NM, MS, KY, NJ, MN, GA, CO, MA, SD, TN, MO, PA, MT, SC, NE, KS, VA, AL, NV, WY, OR, PR, MO, OK, GU, HI, AR, ME, VT, CT, NC and the countries of Canada and Mexico.
  • Descripción del producto
    Reagent Management System (RMS) || Dimension EXL with LM || Product Usage: || The Reagent Management System (RMS) is a module for use with the Dimension¿ clinical chemistry system. The RMS doubles the available storage of refrigerated Flex¿ reagent cartridges on the Dimension¿ system from 44 to 88. The RMS loads, hydrates, and automatically removes Flex¿ reagent cartridges, allowing the Dimension¿ system to process samples without interruption.
  • Manufacturer
  • Modelo / Serial
    Dimension RxL Max w/o HM Catalog Numbers 752000.901 (Domestic)/752000.921 (Intl). RxL Max HM Catalog Numbers 752000.911 (Domestic)/752000.931 (Intl). All serial numbers.
  • Clasificación del producto
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    US Nationwide Distribution: FL, NY, SC, TX, LA, AZ, WI, IA, IL, OH, AL, AK, NH, OK, MD, CA, NM, MS, KY, NJ, MN, GA, CO, MA, SD, TN, MO, PA, MT, SC, NE, KS, VA, AL, NV, WY, OR, PR, MO, OK, GU, HI, AR, ME, VT, CT, NC and the countries of Canada and Mexico.
  • Descripción del producto
    Reagent Management System (RMS) || Dimension RxL Max w/o HM || Product Usage: || The Reagent Management System (RMS) is a module for use with the Dimension¿ clinical chemistry system. The RMS doubles the available storage of refrigerated Flex¿ reagent cartridges on the Dimension¿ system from 44 to 88. The RMS loads, hydrates, and automatically removes Flex¿ reagent cartridges, allowing the Dimension¿ system to process samples without interruption.
  • Manufacturer
  • Modelo / Serial
    Dimension RXL MAX HM STM Catalog Numbers 752000.941 (Domestic)/752000.951 (Intl). RMS for RxL Catalog Numbers 753000.901 (Domestic)/753000.902 (Intl). All serial numbers.
  • Clasificación del producto
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    US Nationwide Distribution: FL, NY, SC, TX, LA, AZ, WI, IA, IL, OH, AL, AK, NH, OK, MD, CA, NM, MS, KY, NJ, MN, GA, CO, MA, SD, TN, MO, PA, MT, SC, NE, KS, VA, AL, NV, WY, OR, PR, MO, OK, GU, HI, AR, ME, VT, CT, NC and the countries of Canada and Mexico.
  • Descripción del producto
    Reagent Management System (RMS) || Dimension RxL Max HM STM || Product Usage: || The Reagent Management System (RMS) is a module for use with the Dimension¿ clinical chemistry system. The RMS doubles the available storage of refrigerated Flex¿ reagent cartridges on the Dimension¿ system from 44 to 88. The RMS loads, hydrates, and automatically removes Flex¿ reagent cartridges, allowing the Dimension¿ system to process samples without interruption.
  • Manufacturer
  • Modelo / Serial
    DE271317, DE271320, DE271323, DE271324, DE271326, DE271327, DE271328, DE271332 DE271341, DE271343, DE271325, 12252589, 2004082898, 2004082899, 224719-AX
  • Clasificación del producto
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    FL LA AR IA OH OH WI IL LA KS MT
  • Descripción del producto
    Dimension¿ Integrated Chemistry Systems intended to measure a variety of analytes in human body fluids.
  • Manufacturer