Events

Retiro De Equipo (Recall) de Access Immunoassay Systems Access Folate Calibrators, 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 Beckman Coulter Australia 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-2012-RN-00780-3
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2012-08-02
  • 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-2012-RN-00780-3
  • 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
    Beckman coulter has confirmed that the stability, while frozen, for the access folate calibrators may produce falsely elevated results which could mask a folate deficiency. product number a14207 may experience this issue at 12 months, and product number a98033 at 6 months.
  • Acción
    Discontinue and discard remaining inventory. Review the historical quality control data and confirm Access Folate assay performance when using the affected lots in within the laboratory specifications.

Device

Access Immunoassay Systems Access Folate Calibrators, An in vitro diagnostic medical device (IVD)
  • Modelo / Serial
    Access Immunoassay Systems Access Folate Calibrators, Part numbers: A14207, A98033. An in vitro diagnostic medical device (IVD)Part Number: A14207Lot Numbers: 112788 (Expiry Date 30 JUN 2012); 115741 (31 AUG 2012); 118917 (31 OCT 2012)Part Number: A98033Lot Numbers: 122651 (31 JUL 2012); 123635 (30 SEP 2012); 219962 (31 OCT 2012)
  • Manufacturer
    Beckman Coulter Australia Pty Ltd

Manufacturer

Beckman Coulter Australia Pty Ltd