Retiro De Equipo (Recall) de Device Recall ADVIA Chemistry XPT

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 Siemens Healthcare Diagnostics, 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
  • ID del evento
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
  • Fecha de inicio 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
    Electrode, ion specific, sodium - Product Code JGS
  • Causa
    Ise module may produce discrepant, unflagged results for sodium, potassium or chloride when the respective electrode is left unplugged after replacement, washing or maintenance activities. the calibration and 2-level qc will fail if the electrode is left unplugged. the ifu states to calibrate the ises after replacement and to run two levels of controls before running patient samples.
  • Acción
    Urgent Medical Device Correction letters (dated 8/27/2015) and Field Correction Effectiveness Check Forms were sent to customers via FedEx starting on 8/28/2015, informing them of the potential for discrepant ISE results. Customers must follow the instructions provided in the letter. The Actions to Be Taken section of the letter notes that customers must ensure that the electrodes are fully plugged in after replacement, washing or maintenance activities, followed by performing an ISE Calibration and running 2 levels of Quality Control material. Urgent Field Safety Notices were sent to customers outside the USA. The Field Correction Effectiveness Check form should have been completed and returned. A copy of the letter should be kept with laboratory records; and, the letter should be forwarded to anyone who may have received the affected product. Customers should contact their Siemens Customer Care Center or their local Siemens technical support representative with questions.


  • Modelo / Serial
    All serial numbers
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    Worldwide Distribution -- US, Australia, Bahrain, Denmark, Egypt, Egypt, Finland, France, Germany, Italy, Netherlands, New Zealand, Norway, Republic Korea, Singapore, Slovakia, Spain, and the United Kingdom.
  • Descripción del producto
    ADVIA Chemistry XPT Chemistry Systems, Siemens Material Number (SMN) 10723034. || An automated, clinical chemistry analyzer that runs tests on serum, plasma, urine, or cerebral spinal fluid in random access and batch modes.
  • Manufacturer


  • Dirección del fabricante
    Siemens Healthcare Diagnostics, Inc., 511 Benedict Ave, Tarrytown NY 10591-5005
  • Empresa matriz del fabricante (2017)
  • Source