Events

Retiro De Equipo (Recall) de i-STAT troponin I Assay Cartridges (cTnl). 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-2016-RN-00230-1
  • Clase de Riesgo del Evento
    Class III
  • Fecha de inicio del evento
    2016-03-01
  • 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-2016-RN-00230-1
  • 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 (apoc) has determined that there is a possibility that a very small percentage of i-stat ctni cartridges distributed from the affected lot number may have a product identifier other than ctni embossed on the thumbwell of individual cartridges. the outside box and cartridge pouch were labelled correctly for these specified lots. the ctni cartridges from the affected lot can continue to be used for patient testing. the internal components, such as the reagent and analysis solution, are not impacted and the i-stat system will appropriately recognise the cartridge as ctni.
  • Acción
    Abbott Point of Care is advising customers that a product replacement will be provided for any impacted stock.

Device

i-STAT troponin I Assay Cartridges (cTnl). An in vitro diagnostic medical device (IVD)

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