Events

Retiro De Equipo (Recall) de Immulite (all systems) - Sample Cup Holders and Microsample Inserts. In vitro diagnostic medical devices (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-00520-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-06-17
  • 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-00520-1
  • 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 conductive material of the sample cup holders and microsample inserts, which are used to process samples, do not meet specification for facilitating sample level sensing. when sample level sensing is compromised, sample will not be pipetted and the test or tests ordered for the sample will not be run.
  • Acción
    This issue has been corrected for future lots of sample cup holders and microsample inserts. Siemens is requesting laboratories to cease using the faulty sample cup holders and microsample inserts until unaffected sample receptacles are received.

Device

Immulite (all systems) - Sample Cup Holders and Microsample Inserts. In vitro diagnostic medical ...
  • Modelo / Serial
    Immulite (all systems) - Sample Cup Holders and Microsample Inserts. In vitro diagnostic medical devices (IVD)Sample Cup Holder used on Immulite/Immulite 1000 SystemsSiemens Material Number: 10385360 (Set 1-50)Lot number: 15, 16Microsample Insert used on Immulite 2000 / 2000 Xpi SystemsSiemens Material Number: 10385209 (Set of 15)Lot number: 18, 19, 20ARTG Number: 174399
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

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