Events

Retiro De Equipo (Recall) de VITROS ECI IMMUNODIAGNOSTIC PRODUCTS TOTAL-B-HCG II REAGENT PACK

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
    62307
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2016-02-23
  • 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 (ortho) has confirmed that when testing was conducted using lot numbers 1410 1440 1460 and 1470 vitros systems generated results within the measuring range for samples known to not contain measurable hcg. customers reported that their vitros system reported results up to approximately 7.40 miu/ml (iu/l) for patient samples that should have been less than the measuring range of the assay (<2.39 miu/ml (iu/l)).

Device

VITROS ECI IMMUNODIAGNOSTIC PRODUCTS TOTAL-B-HCG II REAGENT PACK
  • Modelo / Serial
    Model Catalog: 6802221 (Lot serial: 1470); Model Catalog: 6802220 (Lot serial: 1470); Model Catalog: 6802221 (Lot serial: 1460); Model Catalog: 6802220 (Lot serial: 1440); Model Catalog: 6802221 (Lot serial: 1410); Model Catalog: 6802220 (Lot serial: 1410); Model Catalog: 6802221 (Lot serial: 1440); Model Catalog: 6802220 (Lot serial: 1460)
  • Descripción del producto
    VITROS Immunodiagnostic Products Total beta-hCG II (Reagent Pack and Calibrator)
  • Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS

Manufacturer

ORTHO-CLINICAL DIAGNOSTICS