Events

Retiro De Equipo (Recall) de Dimension TACR (Tacrolimus) Flex Reagent Cartridge (DF107), 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-00392-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2013-05-02
  • 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-00392-1
  • 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
    Siemens previously communicated an issue with low bias on patient results for dimension tacrolimus flex reagent cartridge lot fa3316 (urgent medical device recall dc 13-02a and tga ref rc-2013-rn-00050-1). siemens will be implementing linking of specific dimension tacr calibrator lots with specific dimension tacr flex lots to ensure accurate recovery and continued traceability of patient results to the lcms reference method. due to the requirement for linked calibrators, lots 2ed072 and 2kd084 can no longer be used.
  • Acción
    Siemens is requesting customers to immediately discard any remaining Dimension TACR (DF107) Flex lot 2ED072 and 2KD084. To ensure the correct linkage between calibrator and reagent lots, customers are requested to contact their Siemens customer service to order lot linked combinations.

Device

Dimension TACR (Tacrolimus) Flex Reagent Cartridge (DF107), An in vitro diagnostic medical device...

Manufacturer

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