Events

Retiro De Equipo (Recall) de Access AMH QC Kits for use with Access Family of Immunoassay Systems. 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-2016-RN-00859-1
  • Clase de Riesgo del Evento
    Class III
  • Fecha de inicio del evento
    2016-06-29
  • 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-2016-RN-00859-1
  • 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
    Beckman coulter has identified that the quality control (qc) value card includes incorrect standard deviation values for the access amh qc kit, lot 689202. the qc value card for this lot lists the following standard deviation values: qc1 as 0.02, qc2 as 0.11 and qc3 as 0.65. the correct standard deviation values are as follows: qc1 is 0.15, qc2 is 0.76 and qc3 is 2.30. use of this restrictive qc range may result in qc failures but there is no impact to patient results.
  • Acción
    Beckman Coulter is advising users to use the correct QC values, as provided, when establishing QC ranges for the affected lot. Users should also confirm that the Access AMH QC assigned mean and standard deviation values are set appropriately per individual laboratory procedures. This action has been closed-out on 20/02/2017.

Device

Access AMH QC Kits for use with Access Family of Immunoassay Systems. An in vitro diagnostic medi...
  • Modelo / Serial
    Access AMH QC Kits for use with Access Family of Immunoassay Systems. An in vitro diagnostic medical device (IVD).Reference Number: B13129Lot Number: 689202Expiry date: 16 September 2017ARTG Number: 213976
  • Manufacturer
    Beckman Coulter Australia Pty Ltd

Manufacturer

Beckman Coulter Australia Pty Ltd