Events

Retiro De Equipo (Recall) de Alkaline Phosphatase (ALPAMP and ALPDEA), 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-00047-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2013-01-18
  • 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-00047-1
  • 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
    The affected lots demonstrate an increased incidence of absorbance flags, (u, u) and //// errors. absorbance flags u and u indicate abnormal high absorbance exceeding either the blank or sample limit. absorbance flag //// indicates a calculation error and no result is generated by the system.
  • Acción
    Siemens Healthcare is advising customers to discontinue use and discard any affected lots. Replacement kits will be provided at free of charge. The increased rate of absorbance flags has not been associated with inaccurate results.

Device

Alkaline Phosphatase (ALPAMP and ALPDEA), An in vitro diagnostic medical device (IVD)
  • Modelo / Serial
    Alkaline Phosphatase (ALPAMP and ALPDEA), An in vitro diagnostic medical device (IVD)Test code: ALPAMPCatalogue number: 03035814Siemens Material Number: 10309049Lot numbers: 255406, 260121Test code: ALPDEACatalogue number: 03036535Siemens Material Number: 10341131Lot number: 255465ARTG 176331
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

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