Events

Retiro De Equipo (Recall) de Product-CD30 (Ber-H2) Incorrect Primary Antibody Expiration Dating

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Roche Diagnostics Australia Pty Limited.

¿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-00690-1
  • Clase de Riesgo del Evento
    Class III
  • Fecha de inicio del evento
    2015-07-28
  • 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-00690-1
  • 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
    Ventana medical systems, inc. (ventana) would like to inform you that the expiration date of the ventana cd30 (ber-h2) mouse monoclonal primary antibody (part number 790-4858, roche material number 07007841001) was inadvertently labelled with a 24 month expiration date for the referenced lot numbers. based on extensive testing of the affected lots, ventana can only support an 18 month expiration date.
  • Acción
    Roche is requesting their customers to stop use of the affected product. Roche is also recommending that any clinical cases tested after the actual expiration date be re-tested in accordance with your local laboratory practices and policies, especially if tissue and/or same-slide controls were not performed in association with the original case. This action has been closed-out on 05/09/2016.

Device

Product-CD30 (Ber-H2) Incorrect Primary Antibody Expiration Dating
  • Modelo / Serial
    Product-CD30 (Ber-H2) Incorrect Primary Antibody Expiration DatingAffected lot numbers: D04835Z, D09123, E00209, E03668, E04391, E05896ARTG Number: 175635
  • Manufacturer
    Roche Diagnostics Australia Pty Limited

Manufacturer

Roche Diagnostics Australia Pty Limited