Events

Retiro De Equipo (Recall) de Phenocell B 0.8% and 3% and Abtectcell III 0.8%RhD. 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 Seqirus 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-2017-RN-00658-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-06-05
  • 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-2017-RN-00658-1
  • 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
    Seqirus has identified that donor #4138503 was listed as d - (negative) on the antigen composition sheet(s) provided with the affected products. subsequent testing of this donor has indicated weak d reactivity. donor #4138503 may be agglutinated by some examples of anti d and the weak d antigen expression of this donor is only detectable by some test methods. this donor has been identified as a possible weak d variant.
  • Acción
    Seqirus has provided users with an interim workaround in the Customer Letter.

Device

Phenocell B 0.8% and 3% and Abtectcell III 0.8%RhD. An in vitro diagnostic medical device (IVD)
  • Modelo / Serial
    Phenocell B 0.8% and 3% and Abtectcell III 0.8%RhD. An in vitro diagnostic medical device (IVD)Phenocell B 0.8%Item Number: 26530201Lot Number: 2653164Cell Number: Cell #6Phenocell B 3%Item Number: 16640201Lot Number: 1664164Cell Number: Cell #6Abtectcell III 0.8% RhD Negative Screening CellsItem Number: 22230201Lot Number: 2223123Cell Number: Cell #1Expiry Date: 12/06/2017ARTG Number: 223867
  • Manufacturer
    Seqirus Pty Ltd

Manufacturer

Seqirus Pty Ltd