Events

Retiro De Equipo (Recall) de Immulite 2000 and Immulite 2000 XPi – Italian Cypress Allergen

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-00401-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-05-13
  • 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-00401-1
  • 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 confirmed that the immulite 2000/immulite 2000 xpi italian cypress allergen lot 206 does not meet the shelf-life stability as indicated on the label. this may lead to single class change decrease (standard classification) in patient results across the current shelf-life of this allergen lot. patient dose values may decrease before the stated expiry date listed on the allergen vial.It is expected that lot 208 will also not meet its current shelf life stability and must be discarded after june 30, 2015.
  • Acción
    Siemens is requesting laboratories to discard IMMULITE 2000/IMMULITE 2000 XPi Italian Cypress allergen from lot 206. The shelf-life of IMMULITE 2000/IMMULITE 2000 XPi Italian Cypress allergen, lot 208, has been shortened to June 30, 2015. Laboratories are requested to discontinue use and discard lot 208 after June 30, 2015.

Device

Immulite 2000 and Immulite 2000 XPi – Italian Cypress Allergen
  • Modelo / Serial
    Immulite 2000 and Immulite 2000 XPi – Italian Cypress AllergenSiemens Material Number: 10386079Lot Numbers: 206 and 208ARTG number: 198420
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

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