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-00792-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-07-24
  • 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-00792-1
  • 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 indicate a decrease in the od (optical density) of the calibrator affecting the performance of the kit over a period of time resulting in inappropriate treatment. results of confirmative testing were found to show increased false positives. the values of calibrator and positive control were out of specification (manufacturing range).
  • Acción
    Alere is requesting their customers to immediately discontinue use and destroy all remaining units of the recalled lot. Replacement product is expected to be available in approximately 3 – 4 weeks. Until that an alternate method of testing Q-Fever should be investigated. This action has been closed-out on 03/06/2016.

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