Events

Retiro De Equipo (Recall) de VITROS 3600 IMMUNODIAGNOSTIC SYSTEM - INSTRUMENT

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
    58440
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2013-05-13
  • 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
    Ocd has received several reports of condition codes that occurred during the calibration of microwell assays. internal investigation determined that the microwell shuttle weight on some vitros systems may be uncoated and therefore out of our manufacturing specifications. if an uncoated microwell shuttle weight is installed and calibration of microwell assays is not performed biased results could potentially occur. internal testing determined that quality control results using an uncoated well weight showed on average a 10% shift from established means that was within the quality control ranges. the magnitude of the bias is not likely to impact patient safety.

Device

VITROS 3600 IMMUNODIAGNOSTIC SYSTEM - INSTRUMENT
  • Modelo / Serial
    Model Catalog: 6802783 (Lot serial: 36000627); Model Catalog: 6802783 (Lot serial: 36000264); Model Catalog: 6802783 (Lot serial: 36000130); Model Catalog: 680 2413 (Lot serial: > 10 contact manufacturer)
  • Descripción del producto
    VITROS 3600 Immunodiagnostic System
  • Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS

Manufacturer

ORTHO-CLINICAL DIAGNOSTICS