Events

Retiro De Equipo (Recall) de Cobas IT 3000 Haematology Performance Suite, keyboard differential keyboard (with Cobas IT 3000 versions 2.03.08 to 2.04.00). 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 Roche Diagnostics Australia Pty Limited.

¿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-2012-RN-00782-3
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2012-08-08
  • 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-2012-RN-00782-3
  • 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
    There is a potential that the analyte comments may be deleted if the specific analyte is not counted in the mask. this risk is avoided in the case that the user makes comments against the “blood film comments” analyte for reporting blood film comments. the differential keyboard orders a profile that contains all of the additional blood cell types that can be manually counted. in many instances these additional cell types will not be identified in the count and will not receive a result (eg blasts, myelocytes, etc). the expected behaviour is that if a cell is not counted, then these analytes will be removed from the profile when the final count is accepted.
  • Acción
    Roche is providing work around instructions until a software upgrade can be implemented to permanently fix the issue.

Device

Cobas IT 3000 Haematology Performance Suite, keyboard differential keyboard (with Cobas IT 3000 v...
  • Modelo / Serial
    Cobas IT 3000 Haematology Performance Suite, keyboard differential keyboard (with Cobas IT 3000 versions 2.03.08 to 2.04.00). An in vitro diagnostic medical device (IVD)
  • Manufacturer
    Roche Diagnostics Australia Pty Limited

Manufacturer

Roche Diagnostics Australia Pty Limited