Events

Retiro De Equipo (Recall) de EnVision Flex/HRP visualisation reagent, part of EnVision Flex/Flex+ Kits(For invitro diagnostics use. Intended for use in immunohistochemistry)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Dako 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-2015-RN-00964-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-10-12
  • 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-00964-1
  • 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
    Dako has determined that there is a defect in one lot of a buffer used in the manufacturing of some corresponding lots of the envision flex/hrp visualisation reagent. specifically, some instances of moderate-to-strong non-specific staining and overly-strong specific staining have been observed when this visualisation reagent was used with four antibodies against the biomarkers epstein-barr virus (ebv), mum-1, wilms’ tumor1(wt1) protein and smooth muscle actin (sma). negative control antibodies in the same run were negative, and did not show the non-specific staining.
  • Acción
    Dako is advising users to destroy any remaining lots of affected units. Dako is recommending that users re-evaluate test results from affected lots. This action has been closed-out on 25/08/2016.

Device

EnVision Flex/HRP visualisation reagent, part of EnVision Flex/Flex+ Kits(For invitro diagnostics...
  • Modelo / Serial
    EnVision Flex/HRP visualisation reagent, part of EnVision Flex/Flex+ Kits(For invitro diagnostics use. Intended for use in immunohistochemistry)Multiple products affectedProduct Codes: K8000, K8002, K8023, K8010, K8012, K8024 and GV800Multiple Lot Numbers affectedARTG Number: 199416
  • Manufacturer
    Dako Australia Pty Ltd

Manufacturer

Dako Australia Pty Ltd