Events

Retiro De Equipo (Recall) de VITROS ECI IMUNODIAGNOSTIC SYSTEM ANTI-HCV 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
    50401
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2000-05-29
  • 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
    Have observed a very small number of packs that contained aberrant wells that produced a low signal and may cause a condition code (541-014) or an incorrect result.

Device

VITROS ECI IMUNODIAGNOSTIC SYSTEM ANTI-HCV REAGENT PACK
  • Modelo / Serial
    Model Catalog: 6800731 (Lot serial: ALL LOTS BELOW 161); Model Catalog: 1940667 (Lot serial: ALL LOTS BELOW 161); Model Catalog: 1318450 (Lot serial: ALL LOTS BELOW 161); Model Catalog: 1062306 (Lot serial: ALL LOTS BELOW 100); Model Catalog: 1515154 (Lot serial: ALL LOTS BELOW 112); Model Catalog: 1920115 (Lot serial: ALL LOTS BELOW 100); Model Catalog: 192 5551 (Lot serial: ALL LOTS BELOW 112); Model Catalog: 1009406 (Lot serial: ALL LOTS BELOW 112); Model Catalog: 1100387 (Lot serial: ALL LOTS BELOW 71); Model Catalog: 8577413 (Lot serial: ALL LOTS BELOW 71); Model Catalog: 8583130 (Lot serial: ALL LOTS BELOW 90); Model Catalog: 813 6384 (Lot serial: ALL LOTS BELOW 90); Model Catalog: 1009406 (Lot serial: ALL LOTS BELOW 90); Model Catalog: 6800281 (Lot serial: ALL LOTS BELOW 90); Model Catalog: 6800376 (Lot serial: ALL LOTS BELOW 90); Model Catalog: 189 6836 (Lot serial: ALL LOTS BELOW 101); Model Catalog: 6800377 (Lot serial: ALL LOTS BELOW 101); Model Catalog: 8650939 (Lot serial: ALL LOTS BELOW 101); M
  • Descripción del producto
    VITROS IMMUNODIAGNOSTIC PRODUCTS RE PA
  • Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS

Manufacturer

ORTHO-CLINICAL DIAGNOSTICS