Retiro De Equipo (Recall) de Device Recall Crea Calibration solution

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 Radiometer America 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
    60929
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1008-2012
  • Fecha de inicio del evento
    2011-12-16
  • Fecha de publicación del evento
    2012-02-13
  • Estado del evento
    Terminated
  • País del evento
  • Fecha de finalización del evento
    2014-01-17
  • Fuente del evento
    USFDA
  • 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
    Electrode, ion based, enzymatic, creatinine - Product Code CGL
  • Causa
    When the user activates the dosicap (containing the crea additive) and mounts it onto the bottle, the threads will not seal correctly causing approximately 10% of the solution to leak out when the bottle is placed horizontally for dissolving the additive. this will cause the concentration of creatinin and creatin in the calibration solution to be wrong, and results in a bias on the crea results.
  • Acción
    Radiometer sent a Medical Device Recall letter dated December 28, 2011 to their customers. The letter provided details on the affected devices, description of the problem and actions to be taken. The firm instructed their customers to immediately examine their stock and return any remaining product to Raiometer America Inc. for disposal. The letter states that Radiometer will replace all bottles of the affected lots, at no charge. Customers were asked to complete the attached Recall Response Fax Form and fax to 800-736-0601. For questions regarding the Recall contact Radiometer America Technical support at 1-800-736-0600 opt. 4.

Device

  • Modelo / Serial
    S1827 Part Number: 944-135, lot DV02
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution (USA) including the states of: NY, PA and TN.
  • Descripción del producto
    S1827 Crea Calibration solution 1, 944-135, Lot DV-02 Radiometer Medical, Bronshoj Denmark || Product Usage: || The S1827 Crea Calibration Solution 1 (944-135) Lot DV-02 is a solution used by the ABL 8x7 series creatine analyzers to establish calibration points for measured parameters.
  • Manufacturer

Manufacturer

  • Dirección del fabricante
    Radiometer America Inc, 810 Sharon Dr, Westlake OH 44145-1521
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA