Events

Retiro De Equipo (Recall) de Panocell 16 and Panocell 20. 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-2016-RN-00118-1
  • Clase de Riesgo del Evento
    Class III
  • Fecha de inicio del evento
    2016-02-01
  • 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-00118-1
  • 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
    Reports have been received concerning unexpected positive reactivity when testing donor n3512 with anti-v. donor n3512 was listed as v– (negative) on the master list supplied with these products. immucor have confirmed that this donor is v+ (positive).
  • Acción
    Seqirus is providing a revised master list which correctly identifies Donor N3512 as V+ (positive). Seqirus is asking users to evaluate the impact the amended phenotype information may have on results generated with these product lots as per the users' procedures. This action has been closed-out on 04/05/2017.

Device

Panocell 16 and Panocell 20. An in vitro diagnostic medical device (IVD).
  • Modelo / Serial
    Panocell 16 and Panocell 20. An in vitro diagnostic medical device (IVD).Panocell 16Seqirus Product Item: 2332Pack Size: 1 kit (16 cell panel)Lot Number: 39330Expiry Date: 04/12/2015Panocell 20Seqirus Product Item: 5020Pack Size: 1 kit (20 cell panel)Lot Number: 47436 (expiry 29/01/2016), 23160 (expiry 14/08/2015), 14052 (expiry 12/06/15)ARTG Number: 245555
  • Manufacturer
    bioCSL Pty Ltd

Manufacturer

bioCSL Pty Ltd