Events

Retiro De Equipo (Recall) de Panbio Q Fever IgM ELISA (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 Inverness Medical Innovations Australia Pty Ltd T/A Alere.

¿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-01050-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-09-30
  • 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-01050-1
  • 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
    The manufacturer’s internal investigations of the lot number listed above have indicated kit degradation during stability monitoring, thus affecting the performance of the kit prior to kit expiry. one customer complaint has also been received relating to this issue. due to the instability of the serum used in manufacturing the positive control and calibrator, the values of positive control, calibrator and cut-off were out of specification. the fluctuating values could lead to a potential risk of false positive/false negative results.
  • Acción
    Alere is requesting their customers to immediately discontinue use of this lot and dispose of any remaining affected product and is providing refund for the unused kits. Alere is recommending that a review of the previously reported results be undertaken. Alere is discontinuing this product and requesting the users to investigate an alternative method of testing Q fever. This action has been closed-out on 06/06/2016.

Device

Panbio Q Fever IgM ELISA (An in vitro diagnostic medical device (IVD))

Manufacturer

Inverness Medical Innovations Australia Pty Ltd T/A Alere
  • 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