Device Recall Dimension Vista B2 Microglobulin Flex Reagent Cartridge

  • Modelo / Serial
    Lot #: 15037MA - foreign 15175MA - foreign 15204MA- foreign 15246MA (Distributed in US) 15267MA - foreign
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution and US in the state of CA.
  • Descripción del producto
    Dimension Vista System || B2 Microglobulin Flex reagent cartridge and urine stabilizer || Catalog #K7024 SMN: 10445889 Lot #15246MA || Product Usage: || The B2MIC method is an in vitro diagnostic test for the quantitative measurement of B2-microglobulin in human serum, heparinized plasma, EDTA plasma and urine on the Dimension Vista System. Measurements of B2-microglobulin aid in the diagnosis of active rheumatoid arthritis and kidney disease.
  • Manufacturer
  • 1 Event

Fabricante

  • Dirección del fabricante
    Siemens Healthcare Diagnostics, Inc., 500 Gbc Dr Ms 514, PO BOX 6101, Newark DE 19702-2466
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA