Events

Retiro De Equipo (Recall) de Combur10 Test UX when measured on Urisys 1100. 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-2018-RN-00349-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2018-05-09
  • 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-00349-1
  • 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
    Roche has changed the performance claims for the combur10 test ux when measured on the urisys 1100 analyser.Roche performed internal performance studies, in order to maintain products’ compliance to current regulatory requirements. these studies determined that the limit of detection (lod) of certain parameters when measured on the urisys 1100 analyser varied from the claims stated in the ifu current at the time of testing.Parameters with changed lod are: protein, nitrite, ketone bodies, leukocytes, and blood: intact erythrocytes. note:values for all other parameters measured by the combur10 test ux remain unchanged.The lower lod for visual reading remains unchanged for all parameters.Roche has received no customer complaints worldwide in relation to this issue.
  • Acción
    Roche is advising users to verify negative results for Protein, Nitrite, Ketone bodies, Leukocytes or Blood (intact erythrocytes), by visual reading, using the colour scale provided on the test strip vial. In case of discrepant values, the visually determined value shall be reported.

Device

Combur10 Test UX when measured on Urisys 1100. An in vitro diagnostic medical device (IVD)
  • Modelo / Serial
    Combur10 Test UX when measured on Urisys 1100. An in vitro diagnostic medical device (IVD)Material Number: 11544373049 (100 tests)All Lots lower than 29896103ARTG Numbers: 224003 (Roche Diagnostics Australia - Clinical chemistry biological screening IVDs) 212706 (Roche Diagnostics Australia - Instrument/analyser IVDs)
  • Manufacturer
    Roche Diagnostics Australia Pty Limited

Manufacturer

Roche Diagnostics Australia Pty Limited