Events

Retiro De Equipo (Recall) de LIFECODES HLA-C eRES SSO Typing Kit. 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 Diagnostic Solutions 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-2016-RN-00591-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-05-12
  • 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-2016-RN-00591-1
  • 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
    It has been determined that the threshold set for hla-c eres probes 380, 382, 384 and 385 in lot number 10235b are set high and may result in false negative probe results. the probes resolve the following cwd alleles:• probe 380 resolves c*03:06• probe 382 resolves c*12:13• probe 384 resolves c*01:08 • probe 385 resolves c*08:06.
  • Acción
    Diagnostic Solutions is advising users a correction will be made by replacing the old HLA-C eRES MATCHIT! EXP file with a revised MATCHIT! EXP file, which is specific to this single lot. This action has been closed-out on 02/02/2017.

Device

LIFECODES HLA-C eRES SSO Typing Kit. An in vitro diagnostic medical device (IVD)
  • Modelo / Serial
    LIFECODES HLA-C eRES SSO Typing Kit. An in vitro diagnostic medical device (IVD)Product Code: TL628921Lot Number: 10235BProbes affected: 380, 382, 384, 385ARTG Number: 217872
  • Manufacturer
    Diagnostic Solutions Pty Ltd

Manufacturer

Diagnostic Solutions Pty Ltd