Events

Retiro De Equipo (Recall) de LIAISON Borrelia IgG. 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 DiaSorin Australia 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-2014-RN-01240-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-11-21
  • 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-2014-RN-01240-1
  • 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
    Diasorin has become aware that the kit lots identified have a potential to produce invalid calibrations due to either a calibrator 1 deviation percentage [%] outside the high limit, or due to the gcc (geometrical curve check) out of range. as a consequence the calibration cannot be validated and the testing with these lots on the analyser cannot be performed.
  • Acción
    Diasorin is recommending that use of the affected lot be ceased and any units be discarded. Results obtained with a valid calibration are considered to be reliable; therefore, review of past patient results is not deemed necessary, but at the discretion of the laboratory director. This action has been closed-out on 01/03/2016.

Device

LIAISON Borrelia IgG. An in vitro diagnostic medical device (IVD).
  • Modelo / Serial
    LIAISON Borrelia IgG. An in vitro diagnostic medical device (IVD).Part number: 310880Lot Number: 089054X , 089054X/1 and 089054X/2Expiry date January 9th, 2016 for all three lots ARTG number: 208811
  • Manufacturer
    DiaSorin Australia Pty Ltd

Manufacturer

DiaSorin Australia Pty Ltd