Events

Retiro De Equipo (Recall) de ADVIA Chemistry Systems Lipase Assay

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-00269-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-03-26
  • 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-2015-RN-00269-1
  • 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 healthcare diagnostics has identified the potential for positive biase of advia chemistry systems lipase assay results due to carry-over from one or more of the following tests: · triglycerides, · triglycerides _2, · triglycerides concentrated, · cholesterol concentrated, and · direct ldl reagents. the carryover potential from these reagents is mitigated by setup of designated contamination avoidance protocols. however, in certain circumstances, rare incidences of carryover interference can occur.
  • Acción
    Siemens is actively investigating this situation in an effort to provide an improved contamination avoidance protocol for the Lipase assay to eliminate high-biased ADVIA Chemistry Systems Lipase assay results. Siemens has provided customers with a work around to mitigate this problem from occurring. This action has been closed-out on 01/03/2018.

Device

ADVIA Chemistry Systems Lipase Assay
  • Modelo / Serial
    ADVIA Chemistry Systems Lipase AssayCatalogue Number: B01-4840-01, REF: 01984894Siemens Material Number: 10311896All lot number affectedARTG Number: 176331
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

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