Events

Retiro De Equipo (Recall) de Substrate buffer used with LIFECODES PAK12 and LIFECODES PF4IgG Kits. 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 Shanahan Consulting 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-2012-RN-00789-3
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2012-08-08
  • 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-2012-RN-00789-3
  • 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
    Anomalous decreases in the average optical density (od) have been observed with certain kits within the lifecodes pak product line. the decrease in od was caused by a chemical reaction with an unknown compound that was introduced into the manufacturing process when faulty vials supplied by a third party were used to contain the substrate buffer kit component.
  • Acción
    Quarantine and discard affect products. The sponsor recommends reviewing past valid assay runs and compare Positive Control values obtained with recalled kits against historical trend data and discussing results with healthcare providers to determine if any further testing is required.

Device

Substrate buffer used with LIFECODES PAK12 and LIFECODES PF4IgG Kits. An in vitro diagnostic medi...
  • Modelo / Serial
    Substrate buffer used with LIFECODES PAK12 and LIFECODES PF4IgG Kits. An in vitro diagnostic medical device (IVD)Substrate buffer Lot Number: SB092011used with:LIFECODES PAK12Catalog Number: PAK12Kit Lot Number: 101911P12LIFECODES PF4IgG KitsCatalog Number: HAT45GKit Lot Number: 100311H45G
  • Manufacturer
    Shanahan Consulting Pty Ltd

Manufacturer

Shanahan Consulting Pty Ltd
  • Source
    DHTGA