Events

Retiro De Equipo (Recall) de IMMAGE IMMUNOCHEMISTRY SYSTEM RF RHEUMATOID FACTOR REAGENT

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
    80715
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2011-06-03
  • 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 that for lot numbers m908398 and m911529 of immager immunochemistry systems rheumatoid factor reagent known negative results are being reported as slightly positive (between 20 and 30 iu/ml usually). when tested on other methods or with other lots most of these slightly positive samples read < 20 iu/ml or negative. per the cis 95% of normal healthy individuals who live in southern california should have results less than 20 iu/ml. customers utilizing these lots are reporting patient results in more than 5% of their samples with results greater than 20 iu/ml.

Device

IMMAGE IMMUNOCHEMISTRY SYSTEM RF RHEUMATOID FACTOR REAGENT
  • Modelo / Serial
    Model Catalog: 447070 (Lot serial: M908398); Model Catalog: 447070 (Lot serial: M911529)
  • Descripción del producto
    IMMAGE IMMUNOCHEMISTRY SYSTEM RF RHEUMATOID FACTOR REAGENT
  • 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