Events

Retiro De Equipo (Recall) de Device Recall Dimension Vista CSA and CSAE

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
    67787
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1647-2014
  • Fecha de inicio del evento
    2014-03-19
  • Fecha de publicación del evento
    2014-05-21
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-08-10
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=126326
  • 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
    Cyclosporine - Product Code MKW
  • Causa
    A complaint was received of dimension vista¿ csa and csae under-recovery of cyclosporine when patient samples are run from the small sample container. the under-recovery that has been observed is 18 to 44%. in march 2014, siemens recalled due to the complaint received of dimension vista¿ csa and csae reporting under-recovery of cyclosporine when patient samples are run from the small sample c.
  • Acción
    Siemens sent an Urgent Medical Device Correction letter dated March 2014. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed not to use the SSC with patient samples when running CSE or CSAE. Siemens also recommended a look back at previously generated CSA or CSAE results if the patient samples have been run from the SSC and that the content of this letter should be discussed with the Medical Director. Customers were asked to complete the attached form and fax it to (302) 631-8467. For questions regarding this recall call 800-441-9250.

Device

Device Recall Dimension Vista CSA and CSAE
  • Modelo / Serial
    CSA 13114BA, exp. 2014-04-24; CSA 13157BA, exp. 2014-06-06; CSA 13246BB, exp. 2014-09-03; CSA 13317BA, exp. 2014-11-13; CSA 14008BB, exp. 2015-01-08; CSA 14050BB, exp. 2015-02-19; CSAE 13157BC, exp. 2014-06-06; CSAE 13249BD, exp. 2014-09-06.
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA (nationwide) and Internationally to Canada, Belgium, Switzerland, Germany, Spain, France, Great Britain, Italy, Saudi Arabia, Australia, and Japan.
  • Descripción del producto
    Dimension Vista¿ CSA and CSAE || The Cyclosporine method is an in vitro diagnostic test for the quantitative measurement of cyclosporine A (CSA) in human whole blood on the Dimension Vista¿ System. Measurements of CSA are used as an aid in the management of heart, liver and kidney transplant patients.
  • Manufacturer
    Siemens Healthcare Diagnostics, Inc.

Manufacturer

Siemens Healthcare Diagnostics, Inc.
  • Dirección del fabricante
    Siemens Healthcare Diagnostics, Inc., 500 Gbc Dr Ms 514, PO BOX 6101, Newark DE 19702-2466
  • Empresa matriz del fabricante (2017)
    Siemens Ag
  • Source
    USFDA