Events

Retiro De Equipo (Recall) de CONTOUR NEXT CONTROL SOLUTION (LOW)

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por BAYER INC..

¿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
    84943
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2015-05-25
  • 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
    1.Control result not marked as a control test: bayer healthcare has received user reports on contour next control test results that are higher than the control range published on the packaging of contour next test strips and not recognized as control tests by the meter. all lots of contour next control solution (levels low normal and high) are affected. 2.Control result outside of control range: another issue may affect any control solution lots when used with contour next test strip lots with expiration dates through november 2016. due to unforeseen material variation lots of contour next control solution may give control test results that are outside of the assigned control range as published on the packaging of contour next test strips. these control results are properly marked as control tests by the meter therefore this issue does not impact insulin pumps.

Device

CONTOUR NEXT CONTROL SOLUTION (LOW)
  • Modelo / Serial
    Model Catalog: 7323 (Lot serial: All lots); Model Catalog: 7325 (Lot serial: All lots); Model Catalog: 7324 (Lot serial: All lots)
  • Descripción del producto
    CONTOUR NEXT CONTROL SOLUTION (LOW)
  • Manufacturer
    BAYER INC.

Manufacturer

BAYER INC.
  • Dirección del fabricante
    MISSISSAUGA
  • Empresa matriz del fabricante (2017)
    Bayer AG
  • Source
    HC