Events

Retiro De Equipo (Recall) de ALERE BINAXNOW LEGIONELLA URINARY ANTIGEN CARD

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por ALERE CANADA.

¿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
    42037
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2013-02-06
  • País del evento
    Canada
  • 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
    There is an error in the french translation of the alere binaxnowr legionella urinary antigen card instructions for use revisions 4 and 5. the negative result portion of the result interpretation section in these incorrect revisions states: "a negative specimen will give a single pink-to-purple colored control line in the top half of the window indicating a presumptive negative result. this control line means that the detection part of the test was not done correctly but l. pneumophila serogroup 1 antigen was detected." this is an incorrect statement. the translation should read: "a negative specimen will give a single pink-to-purple colored control line in the top half of the window indicating a presumptive negative result. this control line means that the detection part of the test was done correctly but no l. pneumophila serogroup 1 antigen was detected.".

Device

ALERE BINAXNOW LEGIONELLA URINARY ANTIGEN CARD
  • Modelo / Serial
    Model Catalog: 852-012 (Lot serial: > 10 lot numbers contact mfg); Model Catalog: 852-000 (Lot serial: > 10 lot numbers contact mfg)
  • Descripción del producto
    Alere BinaxNOWr Legionella Urinary Antigen Card
  • Manufacturer
    ALERE CANADA

Manufacturer

ALERE CANADA
  • Dirección del fabricante
    OTTAWA
  • Empresa matriz del fabricante (2017)
    Abbott Laboratories
  • 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