Device Recall Abbott AxSYM AFP

  • Modelo / Serial
    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.
  • Clasificación del producto
  • Clase de dispositivo
    3
  • ¿Implante?
    No
  • Distribución
    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
  • Descripción del producto
    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

Fabricante

  • Dirección del fabricante
    Abbott Laboratories HPD/ADD, 100/200 Abbott Park Road, Abbott Park IL 60064
  • Source
    USFDA