Events

Retiro De Equipo (Recall) de QMS Everolimus Immunoassay (used for the therapeutic monitoring of immunosuppressant drugs). 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.

¿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-01084-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-08-19
  • 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-01084-1
  • 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 manufacturer has determined that the affected lot may yield over-quantitation in patient samples. the manufacturer has conducted an internal assessment of product performance, and determined that over-recovery of whole blood assay results in the sub-therapeutic range by as much as 50% (for example, a reported assay result of 3.75 ng/ml instead of the actual whole blood concentration of 2.5 ng/ml). given standardised medication toxicity and close monitoring of patients for markers of efficacy, the risk of developing serious or long-range adverse health consequences due to a single reported erroneous everolimus concentration result is deemed to be negligible.
  • Acción
    Thermofisher is advising users to discontinue use and destroy any remaining stocks of the affected batch. A credit note will be issued for the affected product. A review of previously generated results should be considered by the laboratory director and treating physician.

Device

QMS Everolimus Immunoassay (used for the therapeutic monitoring of immunosuppressant drugs). An i...
  • Modelo / Serial
    QMS Everolimus Immunoassay (used for the therapeutic monitoring of immunosuppressant drugs). An in vitro diagnostic medical device (IVD)Catalogue Number: 0373852Lot Number: 72258007Expiry Date: 31 July 2017ARTG Number 235822
  • Manufacturer
    Thermo Fisher Scientific

Manufacturer

Thermo Fisher Scientific