Events

Retiro De Equipo (Recall) de VIGIL PROTEIN CONTROL

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por BECKMAN COULTER CANADA L.P..

¿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
    39224
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2013-09-05
  • 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
    Beckman coulter has confirmed differences in recovery of pfb in vigil protein control using pfb reagent lots m206298 m301364 m302049compared to values obtained using previous pfb reagent lots. these control differences are due to a change in the pool of antiserum material that is used in the manufacture of the pfb reagent. thecontrol range tables included in vigil protein control lots m210051 m210052 and m210053 do not reflect pfb values obtained with pfb reagent lots m206298 m301364 and m302049.

Device

VIGIL PROTEIN CONTROL
  • Modelo / Serial
    Model Catalog: 450130 (Lot serial: M210052(Level 2)); Model Catalog: 450125 (Lot serial: M210052(Level 2)); Model Catalog: 450120 (Lot serial: M210052(Level 2)); Model Catalog: 450130 (Lot serial: M210051(Level 1)); Model Catalog: 450120 (Lot serial: M210053(Level 3)); Model Catalog: 450120 (Lot serial: M210051(Level 1)); Model Catalog: 450130 (Lot serial: M210053(Level 3)); Model Catalog: 450125 (Lot serial: M210053(Level 3)); Model Catalog: 450125 (Lot serial: M210051(Level 1)); Model Catalog: 447760 (Lot serial: M302049); Model Catalog: 447760 (Lot serial: M301364); Model Catalog: 447760 (Lot serial: M206298)
  • Descripción del producto
    Vigil Protein Control
  • Manufacturer
    BECKMAN COULTER CANADA L.P.

Manufacturer

BECKMAN COULTER CANADA L.P.
  • Dirección del fabricante
    MISSISSAUGA
  • Empresa matriz del fabricante (2017)
    Danaher Corporation
  • Source
    HC