Events

Retiro De Equipo (Recall) de Device Recall Elecsys Estradiol Assay

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 Roche Diagnostics Operations, 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
    73411
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1277-2016
  • Fecha de inicio del evento
    2016-03-07
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=144234
  • 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
    Radioimmunoassay, estradiol - Product Code CHP
  • Causa
    Due to the risk of a recently identified cross reactivity, the elecsys estradiol assay should not be used when monitoring patient being treated with fulvestrant. customers should be informed that fulvestrant will increase the apparent concentration of estradiol in women being treated with this drug. if treatment with fulvestrant has been altered or discontinued as a result of falsely elevated e.
  • Acción
    Roche sent an Urgent Medical Device Correction letter dated March 7, 2016 via UPS Ground (receipt required) to the consignee list. The letter identified the affected product, problem and actions to be taken. Consignees were instructed to complete the attached fax form and fax it to 1-866-891-1984. For questions contact the Roche Support Network Customer Support Center, 24 hours a day, seven days a week at 1-800-428-2336.

Device

Device Recall Elecsys Estradiol Assay
  • Modelo / Serial
    Part Number Elecsys Estradiol II : 03000079190; all lot numbers are affected.
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    US Nationwide Distribution including Puerto Rico.
  • Descripción del producto
    Estradiol II Elecsys and cobas e analyzers REF 03000079 190; M 6.5mL, R1 8 mL, R2 8 mL, IVD, || For USA: CONTENT M Streptavidin-coated microparticles 0.72 mg/mL; R1 Biotinylated polyclonal anti-estradiol antibody (rabbit) 45 ng/mL; Mesterolone 130 ng/mL; R2 Estradiol derivative, labeled with ruthenium complex 2.75 ng/mL || Product Usage: || Immunoassay for the in vitro quantitative determination of estradiol in human serum and plasma. The electrochemiluminescence immunoassay ECLIA is intended for use on Elecsys and cobas e immunoassay analyzers.
  • Manufacturer
    Roche Diagnostics Operations, Inc.

Manufacturer

Roche Diagnostics Operations, Inc.
  • Dirección del fabricante
    Roche Diagnostics Operations, Inc., 9115 Hague Rd, Indianapolis IN 46256-1025
  • Empresa matriz del fabricante (2017)
    Roche Holding AG
  • Source
    USFDA