Events

Retiro De Equipo (Recall) de i-STAT PT/INR Cartridge (prothrombin time test used for monitoring patients receiving oral anticoagulation therapy) (An in vitro diagnostic medical device (IVD))

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Abbott Australasia Pty Ltd (Point-of-Care 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
    RC-2013-RN-01119-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2013-11-01
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-01119-1
  • Notas / Alertas
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Notas adicionales en la data
  • Causa
    Abbott point of care has determined that the i-stat pt/inr cartridge lots have the potential to exhibit incorrectly elevated results. internal studies have demonstrated that i-stat pt/inr results are elevated by an average of approximately 10% as compared to the international reference preparation (rtf/09) in the therapeutic range of 1.8 to 3.0 inr.
  • Acción
    Abbott Diagnostic is advising users to destroy unused stock. Any remaining stock will be replaced by Abbott. A review of previous results may be performed at the discretion of the laboratory manager.

Device

i-STAT PT/INR Cartridge (prothrombin time test used for monitoring patients receiving oral antico...
  • Modelo / Serial
    i-STAT PT/INR Cartridge (prothrombin time test used for monitoring patients receiving oral anticoagulation therapy) (An in vitro diagnostic medical device (IVD))List Number: 3P89-24Lot Numbers: C103139 to and including C13270AARTG Number: 213851
  • Manufacturer
    Abbott Australasia Pty Ltd (Point-of-Care Division)

Manufacturer

Abbott Australasia Pty Ltd (Point-of-Care Division)
  • 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
    DHTGA