Events

Retiro De Equipo (Recall) de Vitamin D Total 100 Tests and Vitamin D Total 500 Tests (Used with ADVIA Centaur / ADVIA Centaur XP / ADVIA Centaur XPT Systems)

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-2016-RN-01351-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-10-17
  • 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-2016-RN-01351-1
  • 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 a change in correlation between serum and plasma specimen tubes with the advia centaur vitamin d total assay as compared to instructions for use (ifu). the bias observed between serum and plasma samples has the potential to impact interpretation of vitamin d status in the event the patient's vitamin d level is at or near the cut-offs for deficient versus insufficient or insufficient versus sufficient. this may lead to the initiation of unnecessary vitamin d supplementation and/or additional monitoring of vitamin d levels.
  • Acción
    Siemens is advising customers that they may continue to use the ADVIA Centaur Vitamin D Total assay with both serum and plasma specimen types, however, they should consider the bias when evaluating samples in different tube types. Siemens will contact customers when the updated Instructions For Use (IFU) is available for download from Siemens Doc Library.

Device

Vitamin D Total 100 Tests and Vitamin D Total 500 Tests (Used with ADVIA Centaur / ADVIA Centaur ...
  • Modelo / Serial
    Vitamin D Total 100 Tests and Vitamin D Total 500 Tests (Used with ADVIA Centaur / ADVIA Centaur XP / ADVIA Centaur XPT Systems)Catalogue/SMN Numbers: 10699201 and 10699533Kit Lots ending in:065 - Expiry: 09 Nov 2016066 - Expiry: 30 Jan 2017067 - Expiry: 11 Mar 2017068 - Expiry: 23 Apr 2017069 - Expiry: 21 Jul 2017070 - Expiry: 25 Aug 2017ARTG Number: 175700
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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