Events

Retiro De Equipo (Recall) de Thermofisher Remel Bactipstaph Latex Kits

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 & New Zealand.

¿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-2017-RN-01410-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-11-13
  • 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-2017-RN-01410-1
  • 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
    An internal technical investigation by remel has confirmed that the positive control supplied within these kits may be non-reactive. the latex test reagent provided in the kits performs exactly as expected and according to specifications.No other batches or pack sizes of this product are affected.
  • Acción
    Thermofisher is advising users to inspect stock and quarantine any remaining units of the affected batch from use. The requirement for a review of previously generated results is at the discretion of the Laboratory Director.

Device

Thermofisher Remel Bactipstaph Latex Kits
  • Modelo / Serial
    Thermofisher Remel Bactipstaph Latex Kits Items Numbers: R21143Lot Numbers: 104809ARTG number 235680 (Thermo Fisher Scientific Australia & New Zealand - Microbial-isolate identification and testing IVDs)
  • Manufacturer
    Thermo Fisher Scientific Australia & New Zealand

Manufacturer

Thermo Fisher Scientific Australia & New Zealand