Device Recall Alere INRatio PT/INR Test Strips, Alere INRatio

  • Modelo / Serial
    All lots of part numbers: 0100071 and 0100139.
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    Worldwide Distribution -- US nationwide, Canada, South America, EU, Asia Pacific, Africa, and Middle East.
  • Descripción del producto
    Alere INRatio PT/INR Test Strips, Alere INRatio || PT/INR System Professional || - 0100071 Alere INRatio PT/INR Test Strips, Box of 12 || - 0100139 Alere INRatio PT/INR Test Strips, Box of 48 || The test strips are packaged in individually pouched test strips in a labeled box with 12 or 48 test strips per box. || In vitro diagnostic system that provides a quantitative prothrombin time result, expressed in seconds and as an International normalized ratio (INR).
  • Manufacturer
  • 1 Event


  • Dirección del fabricante
    Alere San Diego, Inc., 9975 Summers Ridge Rd, San Diego CA 92121-2997
  • Empresa matriz del fabricante (2017)
  • Comentario del fabricante
    “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