Devices

Device Recall Dimension Vista Cyclosporine Flex reagent cartridge

  • Modèle / numéro de série
    lots 12300BB, exp. 10-26-2013; 12318BB, exp. 11-13-2013; and 13011BB, exp. 1-11-2014.
  • Classification du dispositif
    Clinical Chemistry and Clinical Toxicology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and Canada.
  • Description du dispositif
    Dimension Vista Cyclosporine Flex reagent cartridge || an in vitro diagnostic test for the quantitative measurement of cyclosporine A (CSA) in human whole blood on the Dimension Vista System. Measurements are used as an aid in the management of heart, liver, and kidney transplant patients.
  • 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