Device Recall Dimension Vista ECREA Flex Reagent Cartridge

  • Modelo / Serial
    Catalog number K1270. Lot number 09224AA
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA, including the states of AZ, CA, FL, IA, IL, MT, NC, NY, OR, PA, TX, and WI and countries of Belgium, Italy, Canada, Germany and the Netherlands.
  • Descripción del producto
    Dimension Vista ECREA Flex Reagent Cartridge || The ECREA method is an in vitro diagnostic test for the quantitative measurement of creatinine in human serum, plasma and urine on the Dimension Vista System. Creatinine measurements are used in the diagnosis and treatment of renal diseases in monitoring renal dialysis, and as a calculation basis for other urine analytes.
  • Manufacturer
  • 1 Event

Fabricante

  • Dirección del fabricante
    Siemens Healthcare Diagnostics, Inc., 500 GBC Drive, Mailstop 514, PO BOX 6101, Newark DE 19714-6101
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA