Events

Retiro De Equipo (Recall) de ARCHITECT STAT High Sensitive Troponin-I Reagent Kit. 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-2016-RN-00561-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2016-04-29
  • 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-2016-RN-00561-1
  • 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
    Predictive quality assurance monitoring of architect stat high sensitive troponin-i reagent lots was initiated following a field action on a single lot of architect stat high sensitive troponin-i reagent in january, which impacted only selected countries. as a result, abbott has identified a potential for increased calibration failures prior to the expiration date. there is no impact to generated patient results. there is a potential for delay in results due to calibration errors and failure to calibrate which may lead to delayed treatment of life threatening injury.
  • Acción
    Abbott is advising users that for certain lots, affected products can be used provided the calibration passes. Alternative lots should be ordered as soon as possible, and if the calibration fails to use an alternative lot. Once an unaffected lot is available, any remaining affected lots should be discarded. For certain lots, the expiration date should be amended as instructed. The expiration date for these lots will need to be manually tracked, as the system will maintain the original expiry date. Abbott is advising users that all new stock will have the expiry dates lowered to 4 months until corrective actions can be implemented. This action has been closed-out on 28/02/2018.

Device

ARCHITECT STAT High Sensitive Troponin-I Reagent Kit. An in vitro diagnostic medical device (IVD)
  • Modelo / Serial
    ARCHITECT STAT High Sensitive Troponin-I Reagent Kit. An in vitro diagnostic medical device (IVD)100 Test KitList Numbers: 3P25-25, 3P25-26Multiple Lot Numbers affected500 Test KitList Numbers: 3P25-35, 3P25-36Multiple Lot Numbers affectedARTG Number: 208227
  • 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