Events

Retiro De Equipo (Recall) de VITROS ECI IMMUNODIAGNOSTIC SYSTEM ANTI-HBS REAGENT/CALIBRATOR

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
    58423
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2013-10-29
  • 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
    Ortho clinical diagnostics (ocd) is notifying customers of the potential for non-reproducible and unexpected positive results for negative anti-hbs reagent packs lots 2280 2290 2302 and 2310. these lots were distributed beginning in november 2012 and all lots have now expired. ocd internal data indicates that the rate of occurrence is variable the maximum observed rate of occurrence for the affected lots was 4 out of 104 negative anti-hbs patient samples which represents approximately 3.9% of negative samples tested. users are being advised to review all previously reported results between >12 and <30 miu/ml. a false positive result considers that a person is presumed to be immune to an hbv infection leaving the person susceptible to an hbv infection.

Device

VITROS ECI IMMUNODIAGNOSTIC SYSTEM ANTI-HBS REAGENT/CALIBRATOR
  • Modelo / Serial
    Model Catalog: 1787753 (Lot serial: 2310); Model Catalog: 1524693 (Lot serial: 2310); Model Catalog: 1787753 (Lot serial: 2302); Model Catalog: 1524693 (Lot serial: 2280); Model Catalog: 1787753 (Lot serial: 2290); Model Catalog: 1524693 (Lot serial: 2290); Model Catalog: 1787753 (Lot serial: 2280); Model Catalog: 1524693 (Lot serial: 2302)
  • Descripción del producto
    VITROS Immunodiagnostic Products Anti-HBs Calibrator and Reagent Pack
  • Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS

Manufacturer

ORTHO-CLINICAL DIAGNOSTICS