Retiro De Equipo (Recall) de Device Recall EIA AntidsDNA Test Kit

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 Bio-Rad Laboratories 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
    Anti-dna antibody (enzyme-labeled), antigen, control - Product Code LRM
  • Causa
    The firm received customer complaints of increased positivity rates associated with the anti-dsdna test kits.
  • Acción
    The firm, Bio-Rad, sent an "URGENT: MEDICAL DEVICE RECALL NOTIFICATION" letter dated March 2, 2010 to all customers. The letter described the product, problem and action to be taken by the customers. The customers were instructed to examine their inventory and quarantine the affected kit lots; discard all affected product in accordance with all local, state and federal disposal procedures; complete and return the enclosed MEDICAL DEVICE RECALL RESPONSE FORM via fax to: (510) 741-3954, attn: Bio-Rad CSD Regulatory Affairs Department, and to please re-evaluate all positive patient samples and retest if necessary. If you have any questions, contact Bio-Rad CSD Regulatory Affairs Department at 510-724-7000.


  • Modelo / Serial
    Lot Numbers: 23192011, exp. 10/31/2010 23192043, exp. 12/31/2010 23192491 exp 3/31/2011 23191837 exp. 7/31/2010
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    Worldwide distribution: USA and countries including: Canada, Carribean, Chile, France, Germany, Hong Kong, India, Italy, Japan, New Zealand, Panama, Singapore, South Korea and United Kingdom.
  • Descripción del producto
    Bio Rad brand Autoimmune EIA Anti-dsDNA Test Kit, 576 Tests, || Catalog No. 576DS, Distributed by and Manufactured by: Bio-Rad Laboratories, Inc. Hercules, CA || The Bio-Rad Autoimmune EIA Anti-dsDNA Test is a qualitative enzyme immunoassay (EIA) intended to screen for the presence of dsDNA antibodies in human serum as an aid in the diagnosis of systemic lupus erythematosus (SLE). For In Vitro Diagnostic Use.
  • Manufacturer


  • Dirección del fabricante
    Bio-Rad Laboratories Inc, 4000 Alfred Nobel Dr, Hercules CA 94547-1803
  • Source