Events

Retiro De Equipo (Recall) de ABC1 HLA Typing Tray included in ABC1 / ABC2 Kits. 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 Diagnostic Solutions Pty Ltd.

¿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-00169-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-02-08
  • 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-00169-1
  • 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
    Abc1 hla typing trays included in a single lot of acb1/acb2 kits contain a manufacturing defect that can result in false positive or false negative results.
  • Acción
    Diagnostic Solutions is advising customers to immediately discontinue use of and destroy ABC1 HLA Typing Trays from the affected lot. Replacement kits will be provided. It is recommended that previously reported results are reviewed at the discretion of the clinical or laboratory director. This action has been closed out on 16 June 2017.

Device

ABC1 HLA Typing Tray included in ABC1 / ABC2 Kits. An in vitro diagnostic medical device (IVD).
  • Modelo / Serial
    ABC1 HLA Typing Tray included in ABC1 / ABC2 Kits. An in vitro diagnostic medical device (IVD).Product Code: GT-ABC1/2AULot Number: 3004753Expiration Date: 15 Nov 2017ARTG Number: 236406
  • Manufacturer
    Diagnostic Solutions Pty Ltd

Manufacturer

Diagnostic Solutions Pty Ltd