Retiro De Equipo (Recall) de Immulite 2000 Rubella Quantitative IgG, Immulite 2500 Rubella IgG

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
    Rubella IgG - Product Code LFX
  • Causa
    The recall was initiated because siemens healthcare diagnostics has identified there is the potential for patient results to be biased low (-0.3 sample to cutoff [s/co] ratio units) due to incompatibility of the toxoplasma igm kits with this particular lot of igg/igm sample diluent. all available lots of the immulite 2000/2500 toxoplasma igm kits (l2ktm/l5ktm) are incompatible with diluent lot 150.
  • Acción
    The customer notification was initiated on 10/22/2009 with the firm forwarding an Urgent Field Safety notice with attached Field Correction Effectiveness Check form to the affected consignees informing them of the issue and the products affected. The consignees were informed that Siemens is initiating the Field Correction (FC) to prevent IMMULITE 2000/2500 Toxoplasma IgM from being run with Diluent lot 150. The consignees were instructed in the interim, until replacement kit lots of RUB IgG and CMV IgG are received, your laboratory can continue using Rubella IgG, CMV IgG, or Toxoplasma IgM as long as Diluent Lot 150 is not loaded on the analyzer when running Toxoplasma IgM. Diluent Lot 150 can be used with RUB IgG and CMV IgG. Once the replacements lots are received, any unopened kit lots listed in the above table MUST BE RETURNED to Siemens per instructions that will accompany a separate Fed Ex Call Tag that will explain the proper return of the affected product. The consignees were also instructed to complete the attached Field Correction Effectiveness Check form and fax to the firm's technical solutions center. Additional questions should be directed to the firm at 973-927-2828.



  • Dirección del fabricante
    Siemens Healthcare Diagnostics Inc., 5700 W 96th St, Los Angeles CA 90045-5544
  • Empresa matriz del fabricante (2017)
  • Source