Events

Retiro De Equipo (Recall) de ADVIA Centaur Folate 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-00369-1
  • Clase de Riesgo del Evento
    Class III
  • Fecha de inicio del evento
    2014-03-28
  • 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-00369-1
  • 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 has confirmed one set of customer complaints related to the performance of the advia centaur systems folate assay, kit lots ending in 223. customers observed that the third party controls bio-rad liquichek and bio-rad lyphochek immunoassay plus folate serum controls may give rise to out of range low results with the advia centaur systems folate assay kits.In addition, siemens has confirmed a second set of customer complaints regarding a shift in whole blood patient results for advia centaur systems folate assay kit lots ending in 219 compared to kit lots ending in 222, 224, 225, 226 and 227.
  • Acción
    Siemens is requesting their customers to discard all kit lots ending in 219 and 223 and to notify Siemens of any replacement needs. Kit lots ending in 222, 224, 225, 226, 227 and above can continue to be used as they provide accurate folate results.

Device

ADVIA Centaur Folate Assay
  • Modelo / Serial
    ADVIA Centaur Folate AssayLots Numbers Ending In/Expiration Date219 - 25 March, 2014223 - 12 May, 2014ARTG Number: 175700
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

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