Events

Retiro De Equipo (Recall) de LIFECODES LifeScreen Deluxe (LMX). 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-2015-RN-01026-1
  • Clase de Riesgo del Evento
    Class III
  • Fecha de inicio del evento
    2015-10-20
  • 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-2015-RN-01026-1
  • 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
    During stability testing at test point 9 months, with lmx lot 3002350, immucor observed false positive results with a single sample. the sample is expected to test negative for both hla class i and class ii. the sample gave a qualitative result of ci (-), cii (+), indicating a false positive for hla class ii.
  • Acción
    Diagnostic Solutions is advising users to destroy any remaining stocks of the affected lots. It is recommended that previously reported results are reviewed at the discretion of the laboratory director. This action has been closed-out on 19/08/2016.

Device

LIFECODES LifeScreen Deluxe (LMX). An in vitro diagnostic medical device (IVD).
  • Modelo / Serial
    LIFECODES LifeScreen Deluxe (LMX). An in vitro diagnostic medical device (IVD).Code Number: TL628215Lot Number: 3002350Expiration Date: 15 Nov 2015ARTG Number: 217870
  • Manufacturer
    Diagnostic Solutions Pty Ltd

Manufacturer

Diagnostic Solutions Pty Ltd