Events

Retiro De Equipo (Recall) de ADVIA Chemistry Total Protein_2 reagent (Urine) (UPRO_2). 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 Siemens Ltd Diagnostics Division.

¿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-00523-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2013-05-22
  • 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-00523-1
  • 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
    Due to the formation of a precipitate in affected lots of the advia chemistry upro_2 reagent indicator dye, an increase in failed calibrations and quality control (qc) failures has been observed. these shifts will lead to quality control failures resulting in no patient result being reported with the affected kits.
  • Acción
    Customers are advised to discontinue use and discard all affected lots. This action has been closed-out on 10/02/2016.

Device

ADVIA Chemistry Total Protein_2 reagent (Urine) (UPRO_2). An in vitro diagnostic medical device (...
  • Modelo / Serial
    ADVIA Chemistry Total Protein_2 reagent (Urine) (UPRO_2). An in vitro diagnostic medical device (IVD).Lot number: 149411
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

Siemens Ltd Diagnostics Division
  • Empresa matriz del fabricante (2017)
    Siemens AG
  • Source
    DHTGA