Events

Retiro De Equipo (Recall) de ARCHITECT DHEA-S Reagents. 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-2017-RN-01526-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-12-18
  • 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-01526-1
  • 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 identified that falsely elevated results may be obtained when using the architect dhea-s assay with samples from infants up to 60 days old. the specific cause of the elevated results is currently under investigation. although falsely elevated results have only been observed with samples from infants up to 60 days old, the expected values representative data for children up to 10 years old provided in the architect dhea-s reagent insert should not be used as these reference ranges are being reviewed as part of the investigation.All in-date lots of current reagent inventory are impacted.
  • Acción
    Abbot is advising users to immediately discontinue use of the ARCHITECT DHEA-S assay with samples from infants up to 60 days old and to immediately discontinue use of the ARCHITECT DHEA-S reagent insert Expected Values representative data for children up to 10 years old. Users are advised to review this letter with the Medical Director and follow laboratory protocol regarding the need for reviewing previously reported patient results.

Device

ARCHITECT DHEA-S Reagents. An in vitro diagnostic medical device (IVD)
  • Modelo / Serial
    ARCHITECT DHEA-S Reagents. An in vitro diagnostic medical device (IVD)List Number: 8K27-20 Lot Numbers: 01316K000, 01217A000, 02217D000, 04117H000List Number: 8K27-25Lot Numbers: 01216K000, 01117A000, 02417D000, 00517F000ARTG Number: 196075
  • 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