Events

Retiro De Equipo (Recall) de VITROS Chemistry Products K+ Slides. 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 Ortho-Clinical Diagnostics.

¿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-2013-RN-01238-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2013-11-21
  • 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-2013-RN-01238-1
  • 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
    While performing an internal investigation, ortho clinical diagnostics (ocd) determined that the coatings of the vitros chemistry products k+ slides contain a surfactant that was unintentionally added during the manufacturing process. the affected slides continue to meet intended use and performance specifications, however the long term product performance is unknown.
  • Acción
    OCD is requesting their customers to discontinue use and discard all units from the affected lots. Replacement kits will be provided if required.

Device

VITROS Chemistry Products K+ Slides. An in vitro diagnostic medical device (IVD)
  • Modelo / Serial
    VITROS Chemistry Products K+ Slides. An in vitro diagnostic medical device (IVD)Catalogue Number: 8157596Coatings: 0884, 0885
  • Manufacturer
    Ortho-Clinical Diagnostics

Manufacturer

Ortho-Clinical Diagnostics