Retiro De Equipo (Recall) de ADVIA Chemistry Lactate Dehydrogenase (LDLP and LDPL). 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 Healthcare Pty Ltd.

¿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
  • ID del evento
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
  • País del evento
  • Fuente del evento
  • 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
    Siemens healthcare diagnostics is providing an update to all advia chemistry systems lactate dehydrogenase l-p (ldlp) and lactate dehydrogenase p-l (ldpl) assay instructions for use (ifu). the current intended use section within in the advia chemistry systems lactate dehydrogenase ifu document contains the following statements which will be removed (given these assays are not validated to monitor for cancer therapy):"advia chemistry ldlp: they may also be used to monitor cancer therapy.Advia chemistry ldpl: they may also be used to monitor extensive cancer and cancer therapy.".
  • Acción
    Siemens is advising users to refer to the revised intended use statement in the notification in order to use the assays as defined. Users will be provided with the updated IFU when it becomes available.


  • Modelo / Serial
    ADVIA Chemistry Lactate Dehydrogenase (LDLP and LDPL). An in vitro diagnostic medical device (IVD).ADVIA Chemistry Lactate Dehydrogenase L-PTest Code: LDLPReference Numbers: 07502115 (40 mL) & 03029628 (70 mL)Siemens Material Numbers: 10309501 (40mL) & 10341128 (70 mL)ADVIA Chemistry Lactate Dehydrogenase P-LTest Code: LDPLReference Numbers: 07502999 (40 mL) & 03030863 (70 mL)Siemens Material Numbers: 10309502 (40 mL) & 10341129 (70 mL)All LotsARTG Number: 176331
  • Manufacturer


  • Empresa matriz del fabricante (2017)
  • Source