Events

Retiro De Equipo (Recall) de Monoclonal Mouse Anti-Human Leukaemia, Hairy Cell Clone DBA.44. An in vitro diagnostic medical device.

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-2018-RN-00329-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2018-04-16
  • 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-2018-RN-00329-1
  • 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
    It has been identified that the primary labels of the affected vials of m0880 were mislabelled with an incorrect concentration. the concentration was written to be 187 mg/l. the correct concentration is 485 mg/l.To date, no customer complaints have been received as a result of this issue.
  • Acción
    Agilent Technologies is advising customers to discard any bottles of the affected lots of this product in line with the precautions outlined in the IFU. Agilent will provide replacement product to affected sites who hold unused or partially used vials. Agilent Technologies is advising users who may have run results at an altered dilution due to the larger protein concentration and without appropriate run controls to review results and re-run where required.

Device

Monoclonal Mouse Anti-Human Leukaemia, Hairy Cell Clone DBA.44. An in vitro diagnostic medical de...
  • Modelo / Serial
    Monoclonal Mouse Anti-Human Leukaemia, Hairy Cell Clone DBA.44. An in vitro diagnostic medical device.Code Number: M0880 Lot Numbers: 20033445 and 20042272ARTG Number:183436(Agilent Technologies Australia - Immunohistology cell marker IVDs)
  • Manufacturer
    Agilent Technologies Australia Pty Ltd

Manufacturer

Agilent Technologies Australia Pty Ltd