Events

Retiro De Equipo (Recall) de Elecsys Beta-CrossLaps. 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-2013-RN-00388-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2013-05-03
  • 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-2013-RN-00388-1
  • 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 is revising the package insert claims for the sample stability (serum and heparinised plasma) and biotin interference of elecsys beta-crosslaps. the package insert will be updated to reflect the results of recent internal testing for sample stability testing and biotin interference as follows:- the sample stability claim for serum kept at 20-25 degrees celcius will be revised from 8 hours to 6 hours- the sample stability claim for heparinised plasma kept at 20-25 degrees celcius will be revised from 24 hours to 4 hours- the sample stability claim for heparinised plasma kept at 4-8 degrees celcius will be revised from 24 hours to 8 hours. - the biotin interference claim "the assay should be unaffected by biotin up to 368nmol/l or 90 ng/ml" will be revised to "the assay should be unaffected by biotin up to 123nmol/l or 30ng/ml".
  • Acción
    Roche Diagnostics are providing updated information that reflects the results of recent internal testing. A package insert update will include these changes from August, 2013.

Device

Elecsys Beta-CrossLaps. An in vitro diagnostic medical device (IVD)

Manufacturer

Roche Diagnostics Australia Pty Limited