Events

Retiro De Equipo (Recall) de VITROS CHEMISTRY PRODUCTS SYSTEM - K+ SLIDES (POTASSIUM)

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada 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
    59925
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2013-05-14
  • País del evento
    Canada
  • Fuente del evento
    HC
  • Notas / Alertas
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Notas adicionales en la data
  • Causa
    While performing an internal investigation ocd determined that vitros chemistry products k+ slides coatings 0884 and 0885 contain a surfactant that was unintentionally added during the manufacturing process. the surfactant is used in several vitros slide products but it is not included in the product specifications for vitros k+ slides. ocd has conducted testing that indicates that vitros k+ slides made from coatings 0884 and 0885 are currently meeting their intended use and performance specifications. however at this time we are unable to determine the effect that the addition of the surfactant may have on long-term product performance.

Device

VITROS CHEMISTRY PRODUCTS SYSTEM - K+ SLIDES (POTASSIUM)
  • Modelo / Serial
    Model Catalog: 8157596 (Lot serial: 410208850657); Model Catalog: 8157596 (Lot serial: 410208840049); Model Catalog: 8157596 (Lot serial: 410208850389)
  • Descripción del producto
    VITROS Chemistry Products Potassium (K+) Slides
  • Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS

Manufacturer

ORTHO-CLINICAL DIAGNOSTICS