Events

Retiro De Equipo (Recall) de Access BR Monitor

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 Beckman Coulter 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
    77029
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2074-2017
  • Fecha de inicio del evento
    2017-04-13
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2018-06-04
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=154846
  • 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
    System, test, immunological, antigen, tumor - Product Code MOI
  • Causa
    Following biases observed in the results of the french national quality controls, beckman coulter has been informed that a study completed by the french competent authority agence nationale de s¿curit¿ du medicament et des produits de sant¿ (ansm) showed diagnosed cancer patients in non-remission of their metastatic disease, may have results below the upper reference limit (url) of 31.3 u/ml as stated in the access br monitor instructions for use (ifu).
  • Acción
    An urgent Medical Device Recall letter dated 4/13/17 was sent to customers following biases observed in the results of the French National Quality Controls, Beckman Coulter has been informed that a study completed by the French Competent Authority Agence nationale de s¿curit¿ du Medicament et des produits de sant¿ (ANSM) showed diagnosed cancer patients in non-remission of their metastatic disease, may have results below the upper reference limit (URL) of 31.3 U/mL as stated in the Access BR Monitor instructions for use (IFU). Customers are informed of the impact and the actions to be taken. Customers with any questions regarding the notice are instructed to contact Customer Technical Support Center: ¿ From our website: http://www.beckmancoulter.com ¿ By phone: call 1-800-854-3633 in the United States and Canada. ¿ Outside the United States and Canada, contact your local Beckman Coulter representative.

Device

Access BR Monitor
  • Modelo / Serial
    623913, 625701, 628771, 630349, 633070 and All Future Lots
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Affected geographies: Algeria, Australia, Austria, Bangladesh, Belgium, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Ecuador, Egypt, El Salvador, France, Georgia, Germany, Ghana, Gibraltar, Greece, Guam, Guatemala, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Lebanon, Libya, Lithuania, Malaysia, Mayotte, Mexico, Morocco, Myanmar, Namibia, Nepal, Netherlands, New Zealand, Nigeria, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Puerto Rico, Romania, Russia, Rwanda, Saudi Arabia, Serbia, Sierra Leone, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, United States, Venezuela, Vietnam, Zimbabwe
  • Descripción del producto
    Access BR Monitor, Part No. 387620
  • Manufacturer
    Beckman Coulter Inc.

Manufacturer

Beckman Coulter Inc.
  • Dirección del fabricante
    Beckman Coulter Inc., 250 S Kraemer Blvd, Brea CA 92821-6232
  • Empresa matriz del fabricante (2017)
    Danaher Corporation
  • Source
    USFDA