Retiro De Equipo (Recall) de Device Recall LIGHT DIAGNOSTICS Simulfluor Flu A / Flu B 2 mL Reagent

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 Millipore Corporation.

¿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
    50511
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0954-2009
  • Fecha de inicio del evento
    2008-11-24
  • Fecha de publicación del evento
    2009-03-06
  • Estado del evento
    Terminated
  • País del evento
  • Fecha de finalización del evento
    2012-08-10
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
  • 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
    SimulFluor Flu A/Flu B Immunofluorescence Assay - Product Code GNW
  • Causa
    Certain lots of simulfluor flu a / flu b reagent may cross-react with respiratory synctial virus. the continued use of simulfluor flu a / flu b reagent catalog #5250 may lead to a potential misdiagnosis of influenza b.
  • Acción
    Millipore is performing a voluntary recall by notifying customers and distributors by telephone on November 24, 2008. In addition, an Urgent: Medical Device Recall notification letter with the same date was sent via certified mail. Customers were advised to examine their stock immediately and discontinue the use of the specified lots. Customers were instructed to complete the enclosed Effective Check Survey confirming disposal of defective lots and return this form to Millipore's Regulatory Department. Customer service is to be contacted at 1-800-437-7500 for replacement product. Millipore Corporation will issue credit or replace the recalled lots that customers currently have in inventory.

Device

  • Modelo / Serial
    Lot Numbers JBC1531414, TR1458084, TR1480746, JBC1531421, JH1534500, TR1501923, TR1417106, and TR1422506.
  • Clasificación del producto
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution -- USA including states of AL, CA, CO, CT, FL, ID, IL, KS, MA, MI, MS, NM, NY, OH, OK, OR, PA, SD, TX, UT, VA, VT, WA, WV, and WI and countries of Canada, Mexico, Italy, Belgium,Germany, France, Spain, and United Kingdom.
  • Descripción del producto
    LIGHT DIAGNOSTICS Simulfluor Flu A / Flu B 2 mL Reagent Catalog # 5250 which is a component in the Kit Catalog #3121 Simulfluor Flu A / Flu B DFA kit.
  • Manufacturer

Manufacturer

  • Dirección del fabricante
    Millipore Corporation, 28820 Single Oak Dr, Temecula CA 92590-3607
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA