Events

Retiro De Equipo (Recall) de VerifyNow IIb/IIIa 25 Test and VerifyNow IIb/IIIa 10 Test (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-00273-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-03-03
  • 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-00273-1
  • 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, accumetrics, has determined that the referenced lot of these products may result in the reporting of an erroneous low platelet aggregation unit (pau) result. lower than actual or expected pau values may contribute to excess administration of iib/iiia antiplatelet agents.
  • Acción
    Alere is advising their customers to discontinue use of the affected lots and dispose of any remaining tests. Replacement kits will be provided. Review of past results should be undertaken at the discretion of the Laboratory Medical Director or attending physician.

Device

VerifyNow IIb/IIIa 25 Test and VerifyNow IIb/IIIa 10 Test (An in vitro Diagnostic Medical Device ...
  • Modelo / Serial
    VerifyNow IIb/IIIa 25 Test and VerifyNow IIb/IIIa 10 Test (An in vitro Diagnostic Medical Device (IVD))VerifyNow IIb/IIIa 25 Test Catalogue No. AC85011 Lot: WC0180C Lot Expiry: 21/10/2013VerifyNow IIb/IIIa 10 Test Catalogue No. AC85310 Lot: WC0182D Lot Expiry: 8/7/2014
  • Manufacturer
    Inverness Medical Innovations Australia Pty Ltd T/A Alere

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