Events

Retiro De Equipo (Recall) de Device Recall Dimension Vista(R) Gentamicin (GENT) Flex(R) reagent cartridge, K4012

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
    57366
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1739-2011
  • Fecha de inicio del evento
    2010-11-30
  • Fecha de publicación del evento
    2011-03-21
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-03-19
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=95950
  • 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, gentamicin - Product Code LCD
  • Causa
    False elevation of dimension vista(r) gentamicin results for patients and qc when prior reagent aspirated by the reagent probe is any of the following plasma protein methods: asl, b2mic, b2mu, crp,cysc, hcys, hccrp, ige, igg3, igg4, rf, and stfr resulting in inappropriate patient treatment.
  • Acción
    Siemens Healthcare Diagnostics, Inc. sent an Urgent Field Safety Notice letter dated November, 2010, to all affected customers. Customers were requested to run GENT on a Dimension Vista(R) system that does not run the listed plasma protein methods. Instructions were provided for disabling methods on the instrument to prevent inadvertently testing Gent along with plasma protein methods. Customers were instructed to : Forward the notification to anyone to whom they may have distributed the product. Complete and return the Field Correction Effectiveness Check Form to Siemens Healthcare Diagnostics at (302) 631-8467. For further information contact Siemens Technical Solutions Center at 1-800-441-9250 or their local Siemens representative.

Device

Device Recall Dimension Vista(R) Gentamicin (GENT) Flex(R) reagent cartridge, K4012
  • Modelo / Serial
    All Lots
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution including AL, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS, LA, MA, MD, MI, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY.
  • Descripción del producto
    Dimension Vista(R) Gentamicin (GENT) Flex(R) reagent cartridge, K4012 || This method is an in vitro diagnostic test for the quantitative measurement of gentamicin, an aminoglycoside antibiotic, in human serum and plasma on the Dimension Vista System. Gentamicin measurements may be used in the diagnosis and treatment of gentamicin overdose and in monitoring levels of gentamicin to ensure appropriate therapy.
  • Manufacturer
    Siemens Healthcare Diagnostics, Inc.

Manufacturer

Siemens Healthcare Diagnostics, Inc.
  • Dirección del fabricante
    Siemens Healthcare Diagnostics, Inc., 500 GBC Drive, Mailstop 514, PO BOX 6101, Newark DE 19714-6101
  • Empresa matriz del fabricante (2017)
    Siemens Ag
  • Source
    USFDA