Retiro De Equipo (Recall) de Device Recall OPTIGEN Food 30

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 Hitachi Chemical 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
    Recall
  • ID del evento
    64132
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-0793-2013
  • Fecha de inicio del evento
    2012-12-21
  • Fecha de publicación del evento
    2013-02-07
  • Estado del evento
    Terminated
  • País del evento
  • Fecha de finalización del evento
    2013-05-16
  • Fuente del evento
    USFDA
  • 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
    System, test, radioallergosorbent (rast) immunological - Product Code DHB
  • Causa
    There is no evidence that a visual inspection was performed on one tray of coverslips. possibility of a low fill volume which could lead to a false negative results.
  • Acción
    Hitachi sent an Urgent Product Recall Notification letter dated December 21, 2012, to the affected customer. The letter identified the product, the problem, and the action to be taken by the customer. The customer was instructed to discontinue distribution and destroy any remaining inventory of the affected product at their location per their local waste ordinances, determine if any of their customers are using or have inventory of the affected product, rquest that their customers review all patient results reported with the use of the affectted product. The customer was instructed to tell their customers to discontinue use and destroy any remaining inventory per their local waste ordinances. The customer was instructed to retain a copy of the notification letter for their records. The customer was also instructed to send confirmation of the destruction within 5 days Customers were instructed to complete and return the attached Certificate of Destruction. For questions customers were instructed to contact their local area Customer Service. For questions regarding this recall 650-961-5501.

Device

  • Modelo / Serial
    Catalog number: 85035. Lot number 42K283626, expiration May 31, 2013.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - France only
  • Descripción del producto
    OPTIGEN Food 30; Catalog number: 85035. For allergen testing. || Manufactured by Hitachi Chemical Diagnostics, Mountain View, CA. || Distributed by Theridiag, Cedex, France
  • Manufacturer

Manufacturer

  • Dirección del fabricante
    Hitachi Chemical Diagnostics Inc, 630 Clyde Ct, Mountain View CA 94043-2239
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA