Events

Retiro De Equipo (Recall) de Elecsys HIV combi PT assay. 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 Roche Diagnostics Australia Pty Limited.

¿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-00030-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-01-17
  • 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-00030-1
  • 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
    Recent cases have been reported of a calibration signal shift regarding the elecsys hiv combi pt assay (gmmi kit: 05390095-190) on modular analytics e170, cobas e 601 and e 602 analysers.The reagent packs reporting a calibration signal shift are affected during their use on the instrument. the affected on-board rack packs are identified by the hiv control level 1 (pc hiv level 1) recovering out of range (>3sd) during use.
  • Acción
    Roche Diagnostics is recommending that if users are affected to not re-calibrate the rack pack, discontinue use of the affected pack, record rack pack details of QC and Calibration signals and use a fresh rack-pack with new calibration and follow the instructions given in the package insert. Discarded kits will be replaced by Roche Diagnostics. Roche Diagnostics are continuing to investigate the cause of the issue and will advise users when further information is available. This action has been closed-out on 29/01/2016.

Device

Elecsys HIV combi PT assay. An in vitro diagnostic medical device (IVD)
  • Modelo / Serial
    Elecsys HIV combi PT assay. An in vitro diagnostic medical device (IVD)Lot numbers: 171983, 172659, 173326, 175019, 175493, 175494
  • Manufacturer
    Roche Diagnostics Australia Pty Limited

Manufacturer

Roche Diagnostics Australia Pty Limited