Events

Retiro De Equipo (Recall) de VITROS CHEMISTRY PRODUCTS 51 FS CHEMISTRY SYSTEM - COCM ASSAY

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
    44722
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2013-10-04
  • 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 customer complaints of a downward drift/shift in quality control results or low quality control results when using vitros chemistry products cocm reagent. this drift/shift will likely be observed within approximately 3-14 days of calibration. patient results may be affected in the same manner. our investigation has shown that recalibration will be initially effective in resolving the issue but that increased calibration frequency may no longer be effective over time. ocd internal testing has confirmed that this issue occurs will all lots of vitros cocm reagent that are within expiration dating. as a result customers are being asked to discontinue using and discard all vitros cocm reagent remaining in their inventory.

Device

VITROS CHEMISTRY PRODUCTS 51 FS CHEMISTRY SYSTEM - COCM ASSAY
  • Modelo / Serial
    Model Catalog: 680 1995 (Lot serial: 1525-10-2901); Model Catalog: 680 1995 (Lot serial: 1525-09-2754); Model Catalog: 680 1995 (Lot serial: 1525-10-3062)
  • Descripción del producto
    VITROS Chemistry Products COCM Reagent
  • Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS

Manufacturer

ORTHO-CLINICAL DIAGNOSTICS