Retiro De Equipo (Recall) de CELL-DYN 4000 SYSTEM - INSTRUMENT SOFTWARE

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por ABBOTT LABORATORIES LIMITED. DIAGNOSTIC DIVISION.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    43657
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2003-05-26
  • País del evento
  • Fuente del evento
    HC
  • Notas / Alertas
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Notas adicionales en la data
  • Causa
    The lis may not be able to interpret comment record type 3 using the r9-2 software and immature granulocyte and variant lymphocyte suspect population flags may not be present and alert the physicians.

Device

  • Modelo / Serial
    Model Catalog: 07H91-01 (Lot serial: ALL LOT NUMBERS); Model Catalog: 01H01-03 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: 01H02-03 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: 01H02-01 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: 01H03-01 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: 01H01-01 (Lot serial: ALL SERIAL NUMBERS)
  • Descripción del producto
    CELL-DYN 4000 SYSTEM SOFTWARE R9-2
  • Manufacturer

Manufacturer

  • Dirección del fabricante
    MISSISSAUGA
  • 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
    HC