Events

Retiro De Equipo (Recall) de ADVIA Centaur XPT Immunoassay 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 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
    Recall
  • ID del evento
    74162
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0072-2017
  • Fecha de inicio del evento
    2016-04-28
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2018-06-07
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=146584
  • 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
    Radioimmunoassay, thyroid-stimulating hormone - Product Code JLW
  • Causa
    The advia centaur¿ xpt default setting for the daily maintenance task (daily cleaning procedure) frequency may have the daily maintenance task frequency set to, as needed instead of daily. not performing the daily maintenance may impact any assay and can be detected through monitoring of quality control and calibration results. systems running in a language other than english are not impacted.
  • Acción
    Siemens sent an Urgent Medical Device Correction letter dated April 28, 2016, to all affected customers. The letter advised customers not to release results generated by the system if quality control results are not within acceptable ranges. Customers were advised to perform the following steps to check the Setting for the Daily Maintenance Task frequency on your instrument: *Open the Maintenance Tab, * Select Daily Maintenance task and * Verify that the Frequency Column is set to "Daily at..". The Daily Maintenance Task frequency setting can only be reset by a Siemens Customer Service engineer. If your instrument is set to "As Needed": Daily Maintenance Task Frequency Setting May be Incorrect. Customers should contact their local Technical Support Center to schedule a visit by your Siemens Customer Service engineer. Customers should also perform the daily maintenance by selecting the Daily Maintenance Task and then selecting Perform on the right bar. In addition, all customers were asked to complete and return the Field Correction Effectiveness Check within 30 days. For questions regarding this recall call 914-631-8000.

Device

ADVIA Centaur XPT Immunoassay System
  • Modelo / Serial
    None
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US including MD, MN, & MS; **Internationally** AE, AT, AU, BE, BR, CA, CN, DE, DK, EG, ES, FI, FR, GB, GP, HU, IN, IT, JO, JP, KR, MY, NO, NZ, PH, PT, QA, SA, SE, SG, TR & VN
  • Descripción del producto
    ADVIA Centaur XPT Immunoassay System
  • Manufacturer
    Siemens Healthcare Diagnostics, Inc.

Manufacturer

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