Devices

Device Recall CoaguChek XS System (HCP)

  • Modèle / numéro de série
    Model/Catalog/Part Number: 04837975001 and 04625412160
  • Classification du dispositif
    Hematology and Pathology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution
  • Description du dispositif
    CoaguChek XS System (HCP) || The CoaguChek XS System is intended for use by professional healthcare providers for quantitative prothrombin time testing for the monitoring of warfarin therapy.
  • Manufacturer
    Roche Diagnostics Operations, Inc.
  • 1 Event

Fabricant

Roche Diagnostics Operations, Inc.
  • Adresse du fabricant
    Roche Diagnostics Operations, Inc., 9115 Hague Rd, Indianapolis IN 46256-1025
  • Société-mère du fabricant (2017)
    Roche Holding AG
  • Source
    USFDA