• Dirección del fabricante
    BBI SOLUTIONS OEM LTD, 8 Tom McDonald Avenue, Dundee United Kingdom
  • 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
  • 1 Event

Un dispositivo en la base de datos

  • Modelo / Serial
    Lot Numbers containing test reagent lot # 1012-34437): BU183A, BU183B, BU184A, BU185A, BU185B Expiration Date: 31 JUL 2016
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    US distribution to CT and IN
  • Descripción del producto
    SimpliRED D-Dimer, Product Code DSRK4 || The SimpliRED D-dimer assay is a rapid, qualitative test for the detection of cross-linked fibrin degradation products containing the cross-linked D-diner site in human whole blood