Events

Retiro De Equipo (Recall) de Cell Marque CDX-2 (EPR2864Y*) antibody 7ml - 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 Abacus ALS 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-2013-RN-00776-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2013-07-29
  • 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-2013-RN-00776-1
  • 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
    Cell marque cdx-2 is used to aid in the differentiation of colorectal adenocarcinoma and lung adenocarcinomas. the cdx-2 antibody typically stains the nuclei of colorectal carcinoma cells but not lung adenocarcinoma cells. abacus has advised that the cdx-2 antibody may exhibit a light sporadic, focal, nuclear staining in a limited number of lung adenocarcinomas such as those with enteric differentiation, and may demonstrate slightly stronger staining than other lots.
  • Acción
    Abacus ALS is requesting users to destroy affected stock. Replacement units will be provided as soon as possible. The requirement for a review of patient results reported from this lot should be determined by the laboratory director.

Device

Cell Marque CDX-2 (EPR2864Y*) antibody 7ml - an in vitro diagnostic medical device (IVD)
  • Modelo / Serial
    Cell Marque CDX-2 (EPR2864Y*) antibody 7ml - an in vitro diagnostic medical device (IVD)Catalogue Numbers: CM235R-17 and CM235R-18Lot Number: 1221903
  • Manufacturer
    Abacus ALS Pty Ltd

Manufacturer

Abacus ALS Pty Ltd