Events

Retiro De Equipo (Recall) de IMMULITE/IMMULITE 1000 IMMULITE 2000/IMMULITE 2000 XPi Assays. 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
    Recall
  • ID del evento
    RC-2017-RN-01516-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-12-18
  • 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-2017-RN-01516-1
  • 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 has confirmed through internal investigation that certain immulite/immulite 1000/immulite 2000/immulite 2000 xpi assays are susceptible to biotin interference. this occurs when biotin present in patient samples interferes with the biotin-streptavidin assay architecture on the immulite platform. biotin interference has the potential to bias analytical results of the affected assays. the instructions for use (ifu) currently do not list biotin as a potential interferant.Concentrations of biotin above the determined concentration can potentially result in interference greater than 10%, leading to either falsely elevated or falsely depressed results. cea, folic acid, om-ma (ca125) and vitamin b12 exhibited falsely elevated results with the determined biotin concentrations.3gallergy specific ige, anti hbc, br-ma (ca15-3), ck-mb, epo, gastrin and thyroglobulin exhibited falsely depressed results with determined biotin concentrations.
  • Acción
    Siemens is providing users with updated information regarding biotin interference and updating the Instructions for Use (IFU).

Device

IMMULITE/IMMULITE 1000 IMMULITE 2000/IMMULITE 2000 XPi Assays. An in vitro diagnostic medical dev...
  • Modelo / Serial
    IMMULITE/IMMULITE 1000 IMMULITE 2000/IMMULITE 2000 XPi Assays. An in vitro diagnostic medical device (IVD)Affected Multiple Assay Numbers, Catalogue Numbers and Material NumbersARTG: 179719, 180780, 180969, 179720, 179721
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

Siemens Healthcare Pty Ltd
  • Empresa matriz del fabricante (2017)
    Siemens AG
  • Source
    DHTGA