Events

Retiro De Equipo (Recall) de MAS chemTRAK – H Level 1 Control. 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 Thermo Fisher Scientific 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-2018-RN-00596-1
  • Clase de Riesgo del Evento
    Class III
  • Fecha de inicio del evento
    2018-05-29
  • 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-2018-RN-00596-1
  • 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
    The control's open-vial stability claim for all constituents is "once opened, vials of chemtrak - h are stable for 14 days when stores tightly capped at 2-8deg c". the manufacturer has confirmed that one constituent of the control, glucose, does not meet this stability claim as the recovery of this constituent trends down prior to the stated open-vial usage. the open-vial stability claim of 14 days remains unchanged for the other glucose levels, chu20022a and chu20023a.
  • Acción
    Thermo Fisher are advising customers to continue to use Level 1 of the chemTRAK control after the initial thaw for a period of 5 days and discard the control after this period.

Device

MAS chemTRAK – H Level 1 Control. An in vitro diagnostic medical device (IVD).
  • Modelo / Serial
    MAS chemTRAK – H Level 1 Control. An in vitro diagnostic medical device (IVD). Catalogue Number: CHU-1Lot Number: CHU20021AARTG Number: 192625(Thermo Fisher Scientific Australia Pty Ltd - Multiple clinical chemistry constituent IVDs)
  • Manufacturer
    Thermo Fisher Scientific Australia Pty Ltd

Manufacturer

Thermo Fisher Scientific Australia Pty Ltd