Events

Retiro De Equipo (Recall) de ADVIA Centaur Folate ReadyPack, Lot 071218 Kit Lots (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 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-2013-RN-00778-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2013-07-30
  • 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-2013-RN-00778-1
  • 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 that a portion of folate readypacks in kit lots ending in 218 are exhibiting calibration failures and/or significant negative shifts in quality control (qc) and patient results. if the calibration and qc on a readypack are valid, results generated with this readypack are not affected. however, due to the sporadic nature of the issue, successful calibration and qc on one readypack may not reflect acceptable performance of other readypacks in the lot.
  • Acción
    If a customer has an alternative method or lot of ADVIA Centaur Folate, Siemens Healthcare is advising users to transition all folate testing to the alternative lot or method. Siemens Healthcare is providing users with work around instructions to follow with the affected product. The Laboratory Medical Director should determine if repeat testing of patient samples that demonstrated results below the reference interval is appropriate.

Device

ADVIA Centaur Folate ReadyPack, Lot 071218 Kit Lots (an in vitro diagnostic medical device (IVD))
  • Modelo / Serial
    ADVIA Centaur Folate ReadyPack, Lot 071218 Kit Lots (an in vitro diagnostic medical device (IVD))ADVIA Centaur Folate (100 tests)Kit Lot Numbers: 22288218, 22296218 & 22907218ADVIA Centaur Folate (500 tests)Kit Lot Numbers: 22289218, 22297218 & 22535218ADVIA Centaur Folate (500 tests)Kit Lot Number: 22298218ADVIA Centaur Folate (2500 tests)Kit Lot Number: 22299218Expiration Date: 17 Feb 2014ARTG Number:175700
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

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