Events

Retiro De Equipo (Recall) de VITROS ECI IMMUNODIAGNOSTIC ANALYZER - CLASS II

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
    80204
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2011-08-29
  • 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
    There is a software issue that may affect results from diluted samples run on the vitros eci immunodiagnostic system tested with the vitros immunodiagnostics products total beta-hcg ii reagent pack. ocd has received complaints of observed results from diluted samples that were reported as <2.39 miu/ml (iu/l) instead of the correct 'no result' which is accompanied by an invalid dilution (id) code. the diluted results were inconsistent with results from the neat (undiluted) sample which was within the measuring range of 2.39-15000 miu/ml.

Device

VITROS ECI IMMUNODIAGNOSTIC ANALYZER - CLASS II
  • Modelo / Serial
    Model Catalog: 863 3893 (Lot serial: Lots 0484 and above); Model Catalog: 1922814 (Lot serial: Lots 0484 and above)
  • Descripción del producto
    VITROS ECi/ECiQ Immunodiagnostic Systems Software V 3.8 & below/VITROS Immunodiagnostic Products Total beta-hCG II Reagent Packs Lots 0484 & Above
  • Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS

Manufacturer

ORTHO-CLINICAL DIAGNOSTICS