Events

Retiro De Equipo (Recall) de ARCHITECT Intact Parathyroid (PTH) Assay. 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 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
    RC-2014-RN-00164-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-02-14
  • 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-2014-RN-00164-1
  • 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 has confirmed that a performance shift in the architect intact parathyroid (pth) assay has the potential to generate falsely elevated results on patient samples.Results generated with impacted lots may demonstrate a positive shift averaging approximately 13% to 45% relative to those generated with previous reagent and/or calibrator lots. the issue may also impact your established architect intact pth reference ranges.
  • Acción
    Abbott is advising users to immediately discontinue use and discard affected stock and to identify an alternative method of testing patient samples. Abbott is recommending the letter is reviewed with the treating physician to determine if re-evaluation of the patient is required. This action has been closed-out on 02/02/2016.

Device

ARCHITECT Intact Parathyroid (PTH) Assay. An in vitro diagnostic medical device (IVD)
  • Modelo / Serial
    ARCHITECT Intact Parathyroid (PTH) Assay. An in vitro diagnostic medical device (IVD) List Number: 8K25 Reagent List Numbers: 8K25-20, 8K25-25 Calibrator List Numbers: 8K25-01Control List Numbers: 8K25-10Multiple Lot Numbers affected
  • Manufacturer
    Abbott Australasia Pty Ltd Diagnostic Division

Manufacturer

Abbott Australasia Pty Ltd Diagnostic 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