Device Recall INRatio 2 Monitors

  • Modèle / numéro de série
    All lots of part numbers 0200431, 0200432, 0200433, 0200457, 55112, 55131, and 55128A.
  • Classification du dispositif
  • Classe de dispositif
  • Dispositif implanté ?
  • Distribution
    Worldwide Distribution -- US nationwide, Canada, South America, EU, Asia Pacific, Africa, and Middle East.
  • Description du dispositif
    INRatio 2 Monitors || - 0200431 Alere INRatio 2 PT/INR Professional Testing System || - 0200432 Alere INRatio 2 PT/INR Home Monitoring System || - 0200433 Alere INRatio 2 PT/INR Home Monitoring System || - 0200457 Alere INRatio 2 Replacement Monitor || - 55112 Alere INRatio 2 Replacement Monitor || - 55131 Alere INRatio 2 Replacement Monitor || - 55128A Alere INRatio 2 PT/INR Professional Monitoring System || The test systems contain individually packaged components needed to use the product, such as a monitor, user guide, quick reference guide training DVD or CD, Lancets (home monitoring kits contain an Autolet, Unilet, gauze pads, and alcohol wipes), power supply (home monitoring kits contain AA batteries), results log book and a warranty card. None of the components, except for the lancets, are sterile. || Intended for in vitro diagnostic use for quantitative determination of international normalized ratio (INR) in fresh capillary whole blood to monitor the effect of warfarin on clotting time by health care professionals and home users.
  • Manufacturer
  • 1 Event


  • Adresse du fabricant
    Alere San Diego, Inc., 9975 Summers Ridge Rd, San Diego CA 92121-2997
  • 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