Retiro De Equipo (Recall) de Red Blood Cell Antibody Identification Reagent - Phenocell C 0.8% and Phenocell C 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-2013-RN-00638-1
  • Clase de Riesgo del Evento
    Class III
  • Fecha de inicio del evento
    2013-06-28
  • País del evento
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
  • 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
    The antigen composition sheet supplied with the product listed cell 5 as lu-a 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 does type as lu-a positive (weak reaction – score 5 (0-12 scale)).
  • Acción
    bioCSL is providing end users with an updated Antigen Composition Sheets for affected kits. The updated information is also provided online at www.biocsl.com.au/IH

Device

  • Modelo / Serial
    Red Blood Cell Antibody Identification Reagent - Phenocell C 0.8% and Phenocell C 3%. An in vitro diagnostic medical device (IVD).Phenocell C 0.8%Catalogue number: 96530201Lot number: 9653 052Phenocell C 3%Catalogue number: 86640201Lot number: 8664 052
  • Manufacturer

Manufacturer