Events

Retiro De Equipo (Recall) de FLEX Monoclonal Rabbit Anti-Human Estrogen Receptor Clone EP1, Ready-to-use. 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 Agilent Technologies Australia 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-01330-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2017-10-31
  • 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-01330-1
  • 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
    Agilent has determined that a specific lot of flex monoclonal rabbit anti-human estrogen receptor clone ep1 has shown weak non-specific nuclear and cytoplasmic / stomal staining in known negative samples. in this affected lot some, but not all, breast cancer samples will show weak false-positive staining in some nuclei. this could result in a false-positive result in patient tissue and may not be detected by run controls.To date, agilent has not received any customer complaints regarding this issue.
  • Acción
    Agilent Technologies is advising users to discard affected Ready-to-Use GA084 vials from the affected lots. The vials should be discarded in accordance with the precautions in the Instructions For Use. Agilent will be providing affected users with replacement product in lieu of GA084. Laboratory Managers should review assay runs and patient results where the affected lots were used.

Device

FLEX Monoclonal Rabbit Anti-Human Estrogen Receptor Clone EP1, Ready-to-use. An in vitro diagnost...
  • Modelo / Serial
    FLEX Monoclonal Rabbit Anti-Human Estrogen Receptor Clone EP1, Ready-to-use. An in vitro diagnostic medical device (IVD).Code Number: GA084Lot Number: 10125849Expiry: 31 March 2018ARTG Number: 183436 (Agilent Technologies Australia Pty Ltd - Immunohistology cell marker IVDs)
  • Manufacturer
    Agilent Technologies Australia Pty Ltd

Manufacturer

Agilent Technologies Australia Pty Ltd