Events

Retiro De Equipo (Recall) de Device Recall ADVIA Chemistry Systems Drug Calibrator I

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
    70410
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1321-2015
  • Fecha de inicio del evento
    2015-01-19
  • Fecha de publicación del evento
    2015-03-25
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-09-21
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=133527
  • 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
    Calibrator, multi-analyte mixture - Product Code JIX
  • Causa
    Incorrect calibrator lot values were assigned for advia chemistry systems drug calibrator i, lot 3jd018, for the advia chemistry systems phenytoin 2 (phny_2) and phenobarbital 2 (phnb_2) assays which was the result of calibrator value miscalculation.
  • Acción
    Siemens issued an Urgent Medical Device Correction, on/about January 19, 2015, notifying customers about the product, problem, and action to be taken. Customers were instructed to update the calibrator values for Drug Calibrator 1, Lot 3JD018. All customerswere requested to complete and return the Effectiveness Check questionnaire attached to the Urgent Medical Device Correction letter within (30) days. Field service personnel have been sent an SKB (Service Knowledge Base) describing the issue and instructing them how to deal with customer questions. Customers with questions were instructed to contact their local Siemens technical support representative. For questions regarding this recall call 914-631-8000.

Device

Device Recall ADVIA Chemistry Systems Drug Calibrator I
  • Modelo / Serial
    Material Number 10376770, Lot Number 3JD018, Expiration: April 2015
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US (nationwide) and Internationally to Canada and Mexico.
  • Descripción del producto
    ADVIA Chemistry Systems Drug Calibrator I; For in vitro diagnostic use in the calibration of Phenobarbital_2 (PHNB_2), Phenytoin_2 (PHNY_2), and Theophylline_2 (THEO_2) methods on the ADVIA Chemistry systems. || System Information: (For Information Only) || The ADVIA Chemistry systems are automated, clinical chemistry analyzers that can run tests on human serum, plasma, or urine in random access and batch modes for in vitro diagnostic use. || The ADVIA Chemistry systems are automated, clinical chemistry analyzers that can run tests on human serum, plasma, or urine in random access and batch modes for in vitro diagnostic use.
  • 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