Events

Retiro De Equipo (Recall) de BioCSL Phenocell C Reagent, 3%

Según New Zealand Medicines and Medical Devices Safety Authority, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en New Zealand 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
    14917
  • Fecha de inicio del evento
    2013-07-01
  • País del evento
    New Zealand
  • Fuente del evento
    NZMMDSA
  • URL de la fuente del evento
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notas / Alertas
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Notas adicionales en la data
    Recalling Organisation: Seqirus Pty Ltd, 63 Poplar Road, Parkville, VIC 3052, AUSTRALIA
  • Causa
    The antigen composition sheet supplied with the product listed cell 5 as lua negative. however, a customer complaint was received from the imvs adelaide red cell reference laboratory that they typed cell 5 as lua positive. confirmatory testing performed by biocsl in response to the customer complaint has confirmed that cell 5 did in fact type as lua positive.
  • Acción
    Manufacturer to issue advice regarding use

Device

BioCSL Phenocell C Reagent, 3%
  • Modelo / Serial
    Model: Catalogue Number: 86640201, Affected: Lots: 8664052, 8664053, 8664054
  • Manufacturer
    Seqirus Pty Ltd

Manufacturer

Seqirus Pty Ltd
  • Empresa matriz del fabricante (2017)
    CSL Limited
  • Source
    NZMMDSA