Events

Retiro De Equipo (Recall) de Device Recall Stratus(R) CS Rotors

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
    56976
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0343-2011
  • Fecha de inicio del evento
    2009-12-07
  • Fecha de publicación del evento
    2010-11-10
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2010-11-10
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=95089
  • 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
    Flourometric method, cpk or isoenzymes - Product Code JHX
  • Causa
    Low frequency defect in the gel filling of this lot that may result in inadequate separation of cells in centrifugation.
  • Acción
    The recalling firm, SIEMENS, issued an "Urgent Field Safety Notice" dated December 2009 to all affected customers. The notice described the product, problem and the action to be taken by the customers. The customers were instructed to review the situation with their laboratory director to determine the need to evaluate previously reported test results; immediately examine their CROTOR inventory and discard all bags that are from lot NH42-251-09 including rotors that were not stored in their original packaging (bag); contact Siemens Customer Service Center at 800-241-0420 to request additional no-charge replacements (Note: A "no-charge" order has already been placed so that one bag of replacement rotors would be recieved shortly); forward this notice to anyone they may have distributed this product, and complete and return the FIELD CORRECTION EFFECTIVENESS CHECK via fax at 302-631-8467. If you have any questions regarding this information, please contact the Siemens Technical Solution Center at 800-405-6473.

Device

Device Recall Stratus(R) CS Rotors
  • Modelo / Serial
    catalog number CROTOR, lot number NH42-251-09
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution: USA including states of AK, AZ, AR, CA, FL, GA, HI, IA, IL, IN, KY, LA, MI, MN, MO, MS, MT, NC, ND, NH, NM, NY, OH, TX, UT, WA, WI, and WV and country of Canada
  • Descripción del producto
    Stratus(R) CS Rotors, catalog number CROTOR, lot number NH42-251-09 || Intended use: Stratus(R) rotors is intended for the separation of whole blood samples for analysis on the Stratus(R) CS analyzer
  • 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