Events

Retiro De Equipo (Recall) de ARCHITECT Active-B12 (Holotranscobalamin). 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-2012-RN-01250-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2012-12-10
  • 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-2012-RN-01250-1
  • 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 the architect active-b12 assay is not meeting the method comparison slope claim of 1.0 +/- 0.1 as stated in the package insert (commodity number abbl331/r02). a positive bias of approximately 20-30% has been observed when compared to a commercially available diagnostic kit.This recall action was not notified to the tga before it was initiated by abbott.
  • Acción
    Abbott is providing work around instructions for users to follow and is advising users that once they receive the next reagent lot after the affected lots to re-establish the laboratory's reference ranges prior to evaluating future patient results.

Device

ARCHITECT Active-B12 (Holotranscobalamin). An in vitro diagnostic medical device (IVD)
  • Modelo / Serial
    ARCHITECT Active-B12 (Holotranscobalamin). An in vitro diagnostic medical device (IVD)List Numbers: 3P24-25 / 3P24-35Lot Numbers: 10112UP00, 10113UP00 and 1013UP00
  • 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