Events

Retiro De Equipo (Recall) de Dimension Flex Reagent Cartridge CReactive Protein Extended Range (RCRP)

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
    52000
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-1930-2009
  • Fecha de inicio del evento
    2008-04-15
  • Fecha de publicación del evento
    2009-09-08
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2009-09-09
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=81857
  • 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
    System, test, c-reactive protein - Product Code DCN
  • Causa
    Falsely elevated results in edta plasma samples.
  • Acción
    Siemens Healthcare Diagnostics issued an Urgent Field Safety Notice on April 15, 2008 informing their customers that the EDTA plasma specimen claim had been rescinded. Current lots in the firm's inventory have been put on hold and reworked with an Alert Card rescinding the EDTA plasma claim. Subsequent lots use a revised instruction for use stating "Do not use EDTA plasma" in the Specimen Collection and Handling Section. For further questions, contact Siemens Healthcare Diagnostics at 1-302-631-6564.

Device

Dimension Flex Reagent Cartridge CReactive Protein Extended Range (RCRP)
  • Modelo / Serial
    Catalog Number DF34; Lot Numbers: CE8324 exp 11/19/2008, BA8349 exp 12/14/2008, FB9003 exp1/3/2009, BC9017 exp1/17/2009, EC9021 exp1/21/2009, DB9032 exp2/1/2009, and DC9045 exp2/14/2009.
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution -- US, Austria, Bosnia, Czech Republic, Hungary, Slovakia, Serbia, Denmark, Estonia, Latvia, Lithuania, Norway, Sweden, Belgium, Cyprus, Canary Islands, France, Great Britain, Germany, Ireland, Italy, Netherlands, Poland, Russia, Portugal, Saudi Arabia, Spain, South Africa, Switzerland, Turkey, Yemen, Bahamas, Brazil, Canada, Mexico, Australia, Bangladesh, China, Hong Kong, Japan, Malaysia, Pakistan, and Taiwan.
  • Descripción del producto
    Dimension Flex Reagent Cartridge C-Reactive Protein Extended Range (RCRP). || In vitro diagnostic test intended for the quantitative determination of CRP in human serum and plasma (lithium heparin). Measurement of C-Reactive Protein is useful for the detection and evaluation of infection, tissue injury, inflammatory disorders and associated diseases.
  • 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