Device Recall Martel Printer

  • Modèle / numéro de série
    List number 06F23-91/111300; Abbott list number: 06F23-91 Serial numbers between 20091081 and 241248976.
  • Classification du dispositif
  • Classe de dispositif
  • Dispositif implanté ?
  • Distribution
    Worldwide distribution
  • Description du dispositif
    Martel Printer || The Martel Printer is an accessory to the i-STAT Portable clinical Analyzer (model 300). The i-STAT Analyzer is used by trained medical professionals for running a variety of clinical chemistry tests and test panels contained in i-STAT test cartridges. These tests include Hematocrit, glucose, blood urea nitrogen, sodium, potassium, chloride, ionized calcium, blood gases (oxygen, carbon dioxide, and pH), Creatinine, lactate and activated clotting time.
  • Manufacturer
  • 1 Event


  • Adresse du fabricant
    Abbott Point of Care Inc., 400 College Rd E, Princeton NJ 08540-6607
  • 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