Retiro De Equipo (Recall) de Device Recall ADVIA Centaur Folate

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
  • ID del evento
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
  • Fecha de inicio del evento
  • Fecha de publicación del evento
  • Estado del evento
  • País del evento
  • Fecha de finalización del evento
  • Fuente del evento
  • 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
    Acid, folic, radioimmunoassay - Product Code CGN
  • Causa
    Calibration failures and/or significant negative shifts in quality control (qc) and patient results.
  • Acción
    Siemens sent an Urgent Medical Device Correction letter on July 26, 2013, to all affected customers via Federal Express. The letter identified the product, the problem, and the action to be taken by the customer. an Urgent Field Safety Notice was sent to all domestic customers via Federal Express. On July 25, 2013 this notice was sent to all OUS customers via hard copy, email, and/or fax as determined by each country's local regulations and procedures. These notices inform the customer that a portion of Folate ReadyPacks in kit lots ending in 218 are exhibiting calibration failures and/or significant negative shifts in quality control (QC) and patient results. If customers have an alternate lot of the ADVIA Centaur or ADVIA Centaur CP Folate assay, they are instructed that this lot should be used for future testing. However if no alternative lot is available, quality control (QC) results should be obtained for each individual ReadyPack as a QC or calibration is an indication of an affected pack. An affected pack must be replaced with a different Folate ReadyPack where a valid calibration and acceptable QC values are obtained. These notices should be reviewed by the facility's laboratory or medical director, though no look back is required. Customers were instructed that Fedex Return Receipts will be used to confirm that the customers received the UMDC. Customers with questions were instructed to contact their local Technical Support Provider or Distributor. For questions regarding this recall call 508-668-5000.


  • Modelo / Serial
    22288218, 22296218, 222907218
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    Worldwide Distribution - USA including AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA,MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, TN, TX, UT, VA, VT, WA, WI, WV, and WY. Internationally to Canada and Mexico.
  • Descripción del producto
    ADVIA Centaur Folate (100 Tests), SMN 10310308, Cat No. 06367974 || In vitro diagnostic use in the quantitative determination of folate in serum or red blood cells.
  • Manufacturer


  • Dirección del fabricante
    Siemens Healthcare Diagnostics, Inc, 333 Coney St, East Walpole MA 02032-1516
  • Empresa matriz del fabricante (2017)
  • Source