Events

Retiro De Equipo (Recall) de Abbott RealTime HIV-1 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 Molecular 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-2017-RN-01057-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-08-15
  • 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-2017-RN-01057-1
  • 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 molecular has identified that a specific lot of abbott realtime hiv-1 assay may exhibit a higher than expected rate of error codes. for plasma samples, this has the potential to exhibit false “not detected” results for hiv samples less than 120 copies/ml when using 0.6 ml assay application. for dried blood spot (dbs) samples when using a 1-spot protocol associated with the realtime hiv-1 package insert 51-608282, these are performing in accordance with the detection rate within the realtime hiv-1 package insert for dbs sample types.
  • Acción
    Abbot is requesting users: 1. Review the supplied Abbott Molecular letter carefully and follow the instructions; 2. Complete and return the supplied Customer Reply Form; 3. Contact Abbott Customer Service for assistance if needed. If customers have forwarded the affected product to other laboratories, inform them of this Product Recall and provide to them a copy of the customer letter; and 4. Retain this letter for your laboratory records.

Device

Abbott RealTime HIV-1 Assay. An in vitro diagnostic medical device (IVD)

Manufacturer

Abbott Australasia Pty Ltd Molecular 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