Events

Retiro De Equipo (Recall) de Device Recall Dimension(R) Creatinine Flex(R) Reagent Cartridges

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
    60618
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0772-2012
  • Fecha de inicio del evento
    2011-11-22
  • Fecha de publicación del evento
    2012-01-15
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-04-03
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=105994
  • 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
    Alkaline picrate, colorimetry, creatinine - Product Code CGX
  • Causa
    Siemens has confirmed the potential for falsely elevated creatinine results with crea flex(r) reagent cartridge lots ga2196, ga2203, dc2221, db2221, ga2229 and fa2237 when processing tests from a well that has been punctured.
  • Acción
    Siemens sent an "URGENT FIELD SAFETY NOTICE" dated November 2011 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter recommends that customers discontinue and discard any remaining inventory of the affected product. The firm also recommends customers to test QC at least every 8 hours with lots manufactured after lot FA2237. Additionally, a Field Correction Effectiveness Check form was attached to the letter for customers to complete and return via fax to 302-631-8467. Contact the Siemens Customer Service Center at 888-588-3916 for questions regarding this notice.

Device

Device Recall Dimension(R) Creatinine Flex(R) Reagent Cartridges
  • Modelo / Serial
    Catalog number DF33A and lot numbers GA2196, GA2203, DC2221, DB2221, GA2229 and FA2237.
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution-USA (nationwide) including the District of Columbia and the states of AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, and WY and countries of Albania, Algeria, Angola, Argentina, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belgium, Benin, Bosnia Herzegovina, Botswana, Brazil, Canada, Canary Islands, Ceuta/Mililla, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, Fiji, France, French Guinea, Germany, Great Britian, Greece, Guadeloupe, Guatemala, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Korea, Kuwait, Latvia, Lebanon, Libya, Lithuania, Luxemburg, Macedonia, Mexico, Montenegro, Morocco, Nepal, Nether Antilles, Netherlands, New Zealand, Nicaragua, Norway, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, Reunion, Romania, Russian Federation, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, United Arab Emirates, Uruguay, Venezuela, Vietnam, Yemen and Zimbabwe.
  • Descripción del producto
    Dimension(R) Creatinine Flex(R) Reagent Cartridges. || The CREA method is an in vitro diagnostic test for the quantitative measurement of creatinine in human serum, plasma, and urine on the Dimension Vista System.
  • 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