Events

Retiro De Equipo (Recall) de Remel Wellcolex Colour Shigella Reagent. 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 & 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-01103-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-08-23
  • 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-01103-1
  • 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 thermo fisher scientific has confirmed that specific lots of remel wellcolex colour shigella reagent may notagglutinate in the presence of positive cultures. a negative result indicates that the organisms under test do not belong to the serotypes of shigella species covered by the reagents. latex reagent 2 is used to identify common serotypes of s. dysenteriae and s. boydii. continued use of these lots may result in a failure to correctly identify s. boydii. s.Dysenteriae results are unaffected. latex reagent 1 continues to perform correctly and will identify common serotypes of s. sonnei and s. flexneri.
  • Acción
    1. Inspect your stocks and remove from further use of all units from the impacted batch number, then complete and return the Facsimile Reply Form supplied with the customer letter. 2. If any recalled stock has been transferred from your laboratory to another, inform that laboratory of the recall action.

Device

Remel Wellcolex Colour Shigella Reagent. An in vitro diagnostic medical device (IVD)
  • Modelo / Serial
    Remel Wellcolex Colour Shigella Reagent. An in vitro diagnostic medical device (IVD)Product Code: R30858401Lot Numbers: 1991413, 2130764, 2110576, and 2143554ARTG Number: 236824
  • Manufacturer
    Thermo Fisher Scientific Australia & New Zealand

Manufacturer

Thermo Fisher Scientific Australia & New Zealand