Retiro De Equipo (Recall) de Device Recall Contour Next Control Solution for Contour Next Blood Glucose Test System

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Bayer Healthcare, LLC.

¿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
  • ID del evento
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
  • Fecha de inicio del evento
  • Fecha de publicación del evento
  • Estado del evento
  • País del evento
  • Fecha de finalización del evento
  • Fuente del evento
  • URL de la fuente del evento
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Single (specified) analyte controls (assayed and unassayed) - Product Code JJX
  • Causa
    If the control solution bottle is not thoroughly shaken prior to use, the control test result may be higher than the control range and may not be recognized and marked as a control test by the blood glucose meter. also, the control solution, used as a quality control test in blood glucose meter systems, may read outside the specified range too high or too low.
  • Acción
    On 6/22/2015, Bayer Healthcare began sending URGENT - MEDICAL DEVICE FIELD CORRECTIVE ACTION notifications to affected Health Care Providers, Pharmacies, and Users. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. Customers are instructed to always check the expiration, not to use and discard of expired control solutions. Also, only CONTOUR NEXT control solution should be used with the CONTOUR NEXT test strips. The control solution bottle should be shaken about 15 times before each use. The letter instructed customers to refer to their meter's user guide for further testing instructions. If test results outside the control range are received, another test should be performed following the instructions provided in the letter. If the problem persists, customers should contact Bayer Diabetes Support. Bayer will replace the control solution or provide new control ranges for the test strips, depending on the situation. The firm has implemented improvements to provide more consistent control solution product.


  • Modelo / Serial
    SKU# 7314 (Level 2) and SKU# 7315 (Level 1) All Lots
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    Worldwide Distribution -- USA, Australia, Austria, Belgium, Canada, Croatia, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Slovenia, Spain, Sweden, Switzerland, UK, Albania, Azerbaijan, Bulgaria, Czech Republic, Estonia, Hungary, Korea, Latvia, Lithuania, Philippines, Romania, Serbia, Slovakia, and Thailand.
  • Descripción del producto
    Contour Next Control Solution for Contour Next Blood Glucose Test System. || Liquid quality control solution. Plastic bottle, 2.5mL. || Indicated for use with fresh fingertip capillary whole blood samples.
  • Manufacturer


  • Dirección del fabricante
    Bayer Healthcare, LLC, 430 S Beiger St, Mishawaka IN 46544-3207
  • Empresa matriz del fabricante (2017)
  • Source