Events

Retiro De Equipo (Recall) de AHG Control Cells 3%. 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 bioCSL 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-2015-RN-01145-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-11-24
  • 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-2015-RN-01145-1
  • 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
    There is an issue with the ahg control cells not testing as expected. it is giving very weak positive reactions when it should be giving a strong reaction when validating antiglobulin tests.Ih production has determined that the product was not formulated correctly, as the trial pool of the anti-rh sensitising reagent and the bulk were not made to the same strength due to operator error. this has resulted in the bulk anti-rh sensitising reagent being made 10 x weaker than the trial pool. this weak batch was used for formulating the ahg control cells.
  • Acción
    The sponsor Seqirus is advising customers to inspect stock and quarantine all affected units prior to their return to the sponsor. The sponsor will arrange the replacement of the affected products or credit the account. This action has been clsoed-out on 29/08/2016.

Device

AHG Control Cells 3%. An in vitro diagnostic medical device (IVD)
  • Modelo / Serial
    AHG Control Cells 3%. An in vitro diagnostic medical device (IVD)Item Number: 01901371Lot Number: 019075101Expiry Date: 18/12/2015ARTG Number: 224614
  • Manufacturer
    bioCSL Pty Ltd

Manufacturer

bioCSL Pty Ltd