Events

Retiro De Equipo (Recall) de Clinical Chemistry ICT Serum Calibrator. 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-2014-RN-00828-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2014-07-25
  • 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-00828-1
  • 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
    An abbott investigation has identified that the ict serum calibrator lots above may generate lower than expected potassium qc and patient results. a potential cause of this issue is increased ammonia content over the shelf life of the calibrator. elevated ammonia concentration may impact the potassium calibration and potentially cause a calibration curve to generate the lower results. patient results may have shifted down by 1-3% beyond the acceptable performance of the assay.
  • Acción
    Abbott is advising their customers that if the calibration curve for Potassium is verified with at least two levels of controls according to established quality control requirements for the laboratory, continue to use the lot until new lots are received through the normal ordering processes. If QC results for Potassium are not within established quality control requirements, uses are advised to recalibrate using a different calibrator lot. This action has been closed-out on 03/02/2017.

Device

Clinical Chemistry ICT Serum Calibrator. An in vitro diagnostic medical device (IVD)

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