Device Recall Clearview iFOB Return Mailer (accessory)

  • Modèle / numéro de série
    Lot Numbers:  0630110
  • Classification du dispositif
  • Classe de dispositif
  • Dispositif implanté ?
  • Distribution
    Nationwide Distribution
  • Description du dispositif
    Clearview¿ iFOB, Clearview¿ - Clearview iFOB Return Mailer(accessory) || Product Part Number: || 8117KCV || Intended Use: Immunochemical device intended for the qualitative detection if fecal occult blood in human feces by laboratories or physician offices
  • Manufacturer
  • 1 Event


  • Adresse du fabricant
    Alere North Americal, 30 S Keller Rd Ste 100, Suite 100, Orlando FL 32810-6297
  • Société-mère du fabricant (2017)
  • Commentaire du fabricant
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source