Retiro De Equipo (Recall) de Berichrom Protein C on Sysmex CA-1500, CA-7000, CS-2000i and CS-5100 instruments. 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-2015-RN-00426-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-05-20
  • País del evento
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
  • 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
    The affected berichrom protein c product lots may lead to a failure of calibration on the above sysmex instruments, where the calibration curve is indicated as invalid due to the 0% point of the calibration.
  • Acción
    Siemens advises that in case the Berichrom Protein C calibration curve on your system is indicated as being invalid due to the 0% calibration point the mentioned calibration point has to be set manually to “0” dOD.

Device

  • Modelo / Serial
    Berichrom Protein C on Sysmex CA-1500, CA-7000, CS-2000i and CS-5100 instruments. An in vitro diagnostic medical device (IVD).Berichrom Protein C Catalog numbers: 10446499 and 10446500Lot numbers: 45059 and subsequent, 44851 also affectedARTG number: 178559An in vitro diagnostic medical device (IVD)
  • Manufacturer

Manufacturer

  • Empresa matriz del fabricante (2017)
  • Source
    DHTGA