Device Recall Abbott AxSYM AFP

  • Modèle / numéro de série
    All lots of AFP list 7A48-22 and 7A48-21 used with all lots of AxSYM Cancer Assay Disk list 3D50-02, 3D50-03 and 3D50-04 with AFP Assay File version 2.00.200, when used with AxSYM SYstem Sotware Versions 3.00 and higher.
  • Classification du dispositif
  • Classe de dispositif
    3
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide and internationally to Australia, Canada, Costa Rica, Ecuador, Japan, Panama, San Salvador, Thailand, Barbados, Chili, Curacao, Honduras, Korea, Peru, Singapore, United Kingdom, Brazil, Columbia, Dominican Republic, Hong Kong, Pakistan, St. Vincent, Uruguay
  • Description du dispositif
    AxSYM AFP Reagent Pack, list 7A48-22 (100 test kit), 7A48-21(French label); and AxSYM Cancer Assay Disk, list 3D50-02 (Version 2.0), 3D50-03 (Version 3.0), and 3D50-04 (Version 4.0)
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Abbott Laboratories HPD/ADD, 100/200 Abbott Park Road, Abbott Park IL 60064
  • Source
    USFDA