Events

Retiro De Equipo (Recall) de ARCHITECT STAT High Sensitive Troponin-I Calibrators and Controls

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-2013-RN-00437-1
  • Clase de Riesgo del Evento
    Class III
  • Fecha de inicio del evento
    2013-05-17
  • 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-2013-RN-00437-1
  • 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
    Although the calibrator and control products are currently performing as expected, during internal studies it was noted that architect stat high sensitive troponin-i calibrators and controls may decline in performance prior to their defined expiration dates. these kits were supplied for premarket evaluation of the kit. no patient results were reported from these reagent kits.This recall action was not notified to the tga before it was initiated by abbott australasia.
  • Acción
    Abbott is requesting users to discontinue use and destroy calibrator lot 24057UI00 and control lot 24058UI00. Control lot 26218UI00 can continue to be used, however the expiry date for these units must be changed to 21 July 2013. This action has been closed-out on 11/02/2016.

Device

ARCHITECT STAT High Sensitive Troponin-I Calibrators and Controls
  • Modelo / Serial
    ARCHITECT STAT High Sensitive Troponin-I Calibrators and ControlsARCHITECT STAT High Sensitive Troponin-I Calibrators, LN 3P25-01Lot number: 24057UI000Expiry 9 July 2013ARCHITECT STAT High Sensitive Troponin-I Controls, LN 3P25-10Lot number: 24058UI00, Expiry 8 July 2013Lot number: 26218UI00, Expiry 11 November 2013
  • 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