Events

Retiro De Equipo (Recall) de ADVIA Centaur/Centaur XP/Centaur CP Systems HBc Total (HBcT) 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-2014-RN-01004-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-09-17
  • 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-2014-RN-01004-1
  • 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 increased assay imprecision and a positive bias (increase in index values) in the low end of the assay with the advia centaur systems hbc total (hbct). the increased imprecision and positive bias is observed with patient samples and negative controls and can result in an increase in false reactive results.The increase in the number of false reactive results may cause additional testing but should not result in the reporting of an increased number of false positive results to physicians. the instructions for use (ifu) recommends that clinical interpretation be made in conjunction with other hbv serological markers.
  • Acción
    Siemens is asking customers to discontinue use and discard the affected kit lots. Customers are advised to review the letter with their Medical Director. This action has been closed-out on 18/04/2017.

Device

ADVIA Centaur/Centaur XP/Centaur CP Systems HBc Total (HBcT) Assay
  • Modelo / Serial
    ADVIA Centaur/Centaur XP/Centaur CP Systems HBc Total (HBcT) AssayCatalogue Number: 07566733Siemens Material Number (SMN): 10309508Kit lot numbers: 36217064, 36281064, 36449064, 37406064 and 38177064 Expiration Date: February 10, 2015AUST L number: 93126 An in vitro diagnostic medical device (IVD)
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

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