Events

Retiro De Equipo (Recall) de Device Recall ADVIA Centaur Systems Phenytoin Calibrator N ( PHTN) 6pack

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
    67021
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0930-2014
  • Fecha de inicio del evento
    2013-12-18
  • Fecha de publicación del evento
    2014-02-04
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-05-18
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=124759
  • 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
    Enzyme immunoassay, diphenylhydantoin - Product Code DIP
  • Causa
    Advia centaur¿ systems phenytoin calibrator n, lots cn58 and higher, change in recovery observed with the advia centaur systems phenytoin assay compared to recoveries using previous calibrator n lots.
  • Acción
    Siemens Healthcare Diagnostics Customer Notification notice was sent to affected Siemens Healthcare Diagnostic customers in the United States on December 18, 2013.. The notifications inform customers that Siemens Healthcare Diagnostics received customer feedback regarding the performance of the ADVIA Centara¿ Systems Phenytoin assay, indicating that the assay was recovering higher relative to the performance of other assays in proficiency studies. Siemens internal investigation confirmed the positive bias for Calibrator N lot CN 57 in the ADVIA Centaur Systems Phenytoin assay. This lot has expired and is no longer in use. Expected performance has been restored starting with Calibrator N lot CN58. Siemens is notifying customers that have received Calibrator N lots CN58 and higher that there will be a change in recovery observed with the ADVIA Centaur Systems Phenytoin assay compared to recoveries using previous Calibrator N lots. Siemens is providing data to inform customers of the expected difference between Calibrator lots CN58 and higher versus prior Calibrator N lots. Customers were instructed to retain the letter with their laboratory records, and forward to those who may have received the affected product. Customers with questions were instructed to contact their Siemens Customers Care Center or their local Siemens technical support representative. For questions regarding this recall call 508-668-5000.

Device

Device Recall ADVIA Centaur Systems Phenytoin Calibrator N ( PHTN) 6pack
  • Modelo / Serial
    Lot # Expiry Date  18998A58 06/09/2014; 21854A58 06/09/2014; 25487A59 09/29/2014.
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA (nationwide) and Internationally to Argentina, Australia,Brazil,Canada, Columbia, China, Ecuador, Egypt, India, Japan, Korea, Mexico, Saudi Arabia,Singapore, Thailand, and Uruguay.
  • Descripción del producto
    ADVIA Centaur¿ Systems Phenytoin Calibrator N ( PHTN) 6-pack || SMN 10314977 || For in vitro diagnostic use in the quantitative determination of phenytoin in serum or plasma using the ADVIA Centaur and ADVIA Centaur XP systems
  • Manufacturer
    Siemens Healthcare Diagnostics, Inc

Manufacturer

Siemens Healthcare Diagnostics, Inc
  • Dirección del fabricante
    Siemens Healthcare Diagnostics, Inc, 333 Coney St, East Walpole MA 02032-1516
  • Empresa matriz del fabricante (2017)
    Siemens Ag
  • Source
    USFDA