Events

Retiro De Equipo (Recall) de Device Recall PhD System EIA/IFA Software

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
    Recall
  • ID del evento
    57778
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1726-2011
  • Fecha de inicio del evento
    2011-01-20
  • Fecha de publicación del evento
    2011-03-18
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-08-17
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=97382
  • 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
    Station, pipetting and diluting, for clinical use - Product Code JQW
  • Causa
    Firm's correction involves advising customers who have implemented a laboratory information system (lis) that they need to ensure quantitative results have passed all validation criteria prior to reporting patient results. when a patient result fails a validation rule, the qualitative result will indicate "invalid".
  • Acción
    The firm, Bio-Rad, sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated January 20, 2011 to all customers. The letter described the product, problem and actions to be taken. The customers were instructed to review the PhD Worklist Results to verify that all validations have passed and that the quantitative results are valid; to translate (if necessary) the customer letter, add local contacts information, distribute to all active PhD System customers in their region and provide tracking documentation to CSD-RA for all customers who received the customer letter. If you have any questions, contact the Bio-Rad CSD Regulatory Affairs Department at (510) 741-4618.

Device

Device Recall PhD System EIA/IFA Software
  • Modelo / Serial
    All versions.
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution: USA and countries including:Canada, China, Australia, New Zealand, Czech Republic, France, Hong Kong, India, Italy, Korea, Singapore, Sweden, Taiwan and United Kingdom.
  • Descripción del producto
    PhD System EIA/IFA Software; Model/Catalog Number: 426-0246; || The Bio-Rad PhD System is an EIA and IFA processing system that consists of a PhD fluid handling station(s) linked to a network computer via an Ethernet hub. The network computer provides worklist generation, data management, data reduction and microplate reader control functions. || Product is manufactured by Bio-Rad Laboratories, Inc., Espace European De L Enterprise Strasbourg Schiltigheim, FRANCE
  • Manufacturer
    Bio-Rad Laboratories, Inc.

Manufacturer

Bio-Rad Laboratories, Inc.
  • Dirección del fabricante
    Bio-Rad Laboratories, Inc., 4000 Alfred Nobel Dr, Hercules CA 94547-1803
  • Empresa matriz del fabricante (2017)
    Bio-Rad Laboratories Inc
  • Source
    USFDA