Events

Retiro De Equipo (Recall) de AMH Gen II ELISA Kit. 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-2013-RN-00613-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2013-06-19
  • 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-00613-1
  • 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
    This is a follow up to the urgent recall for product correction (tga reference: rc-2012-rn-01227-1) issued in december 2012. beckman coulter has confirmed that undiluted patient samples measured with the amh gen ii elisa kit may generate results that are lower than expected, due to interference from complement. the previous communication indicated that diluted test results may exceed their true value and that using undiluted samples did not impact test results.
  • Acción
    Beckman Coulter is asking users to discontinue use of all product with lot numbers less than or equal to 326119. It is recommended that all previous test results are evaluated that were not consistent with the patient's clinical presentation. Beckman Coulter are recommending that clinicians are notified of potential erroneous results at the discretion of the Laboratory Director. Update: Beckman Coulter has provided their customer's with updated package insert and instructions to eliminate the complement interference. The updated information includes steps to be taken to determine if the interference issue affects the product and an updated IFU to follow should the assay kit be affected.

Device

AMH Gen II ELISA Kit. An in vitro diagnostic medical device (IVD).
  • Modelo / Serial
    AMH Gen II ELISA Kit. An in vitro diagnostic medical device (IVD). Part number: A79765All lot numbers before and including 326119
  • Manufacturer
    Beckman Coulter Australia Pty Ltd

Manufacturer

Beckman Coulter Australia Pty Ltd