Devices

Device Recall Dimension Vista B2 Microglobulin Flex Reagent Cartridge

  • Modèle / numéro de série
    Lot #: 15037MA - foreign 15175MA - foreign 15204MA- foreign 15246MA (Distributed in US) 15267MA - foreign
  • Classification du dispositif
    Immunology and Microbiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution and US in the state of CA.
  • Description du dispositif
    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
    Siemens Healthcare Diagnostics, Inc.
  • 1 Event

Fabricant

Siemens Healthcare Diagnostics, Inc.
  • Adresse du fabricant
    Siemens Healthcare Diagnostics, Inc., 500 Gbc Dr Ms 514, PO BOX 6101, Newark DE 19702-2466
  • Société-mère du fabricant (2017)
    Siemens Ag
  • Source
    USFDA