Events

Retiro De Equipo (Recall) de Automate 2550 and 1250 Aliquotter Tip Present Sensor.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 Beckman Coulter 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-00084-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2018-02-06
  • 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-00084-1
  • 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
    Beckman coulter has identified a potential issue with the tip present sensor within the robot of the aliquoter module. there has been one overseas report of a misaligned sensor in an automate system, which resulted in the system processing samples without pipette tips. a small number of samples were subject to cross-contamination and were sent to the error rack prior to analysis. in this particular case, the system gave no external sign of a misaligned tip present sensor. there is no impact to the sorter module associated with this issue.
  • Acción
    Beckman Coulter will arrange field service engineers to inspect affected devices to inspect the tip present sensor for misalignment. If users suspect or observe unusual contamination of the tip carrier arm whilst performing daily maintenance, as described in the IFU please contact the local Beckman Coulter representative immediately. If this is to occur, it is recommended to discontinue use of the Aliquotter module.

Device

Automate 2550 and 1250 Aliquotter Tip Present Sensor.An in vitro diagnostic medical device

Manufacturer

Beckman Coulter Australia Pty Ltd