Events

Retiro De Equipo (Recall) de Sorenson’s Buffer. 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-2016-RN-00884-1
  • Clase de Riesgo del Evento
    Class III
  • Fecha de inicio del evento
    2016-07-07
  • 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-00884-1
  • 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
    There are three deficiencies in the current labelling of sorenson’s buffer (ph 6.8 and 7.2). the labels are: 1) missing the dilution instructions, 2) have the incorrect spelling of sorenson’s and 3) do not clearly describe the product as concentrated. thermo fisher scientific has confirmed that the product, apart from the labelling, has not changed in any way. in the event of the product being used undiluted, there is minimal ph variation between the concentrated and diluted solutions (0.2 units) and consequently, no to minimal risk on performance. the corrected label has been applied to all stock on hand at thermo fisher scientific to include the concentration and dilution instructions.The corrected label has been applied to all stock on hand at thermo fisher scientific to include the concentration and dilution instructions.
  • Acción
    Thermo Fisher Scientific is providing users with the correct labels and advising that the correct dilution factor is 1 in 10 diluted with deionised water.

Device

Sorenson’s Buffer. An in vitro diagnostic medical device (IVD)
  • Modelo / Serial
    Sorenson’s Buffer. An in vitro diagnostic medical device (IVD)Product Codes: FNNGG029 and FNNGG030Affected Lot Numbers: 1603216780, 1506195360, 1508200130, 1509202540, 1509203020 and 1510206300ARTG Number: 244172
  • Manufacturer
    Thermo Fisher Scientific Australia Pty Ltd

Manufacturer

Thermo Fisher Scientific Australia Pty Ltd