Events

Retiro De Equipo (Recall) de Device Recall Bionime Rightest Blood Glucose Monitoring System

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 Invictus Scientific 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
    45953
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-0728-2008
  • Fecha de inicio del evento
    2007-11-26
  • Fecha de publicación del evento
    2008-02-16
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-10-13
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=66570
  • 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
    Blood Glucose System - Product Code NBW
  • Causa
    Abnormal memory recall: when the meter is fixed in 12 hour mode, the time frame display of all memory data will be shown incorrectly as am or pm depending on when the user is recalling the memory stored in the meter. this will cause confusion as to when the last test was taken.
  • Acción
    An Urgent: Device Recall Notification letter were sent to customers (direct accounts) beginning on November 20, 2007, via US Postal Service, with a return receipt requested. The distributors were instructed to inform consumers/users to fix the time format to the 24 hrs mode and to contact the distributors or the firm for replacement, if they prefer to use the time format in the 12 hrs mode. They were also instructed that if they have further distributed any of the recalled products, to please immediately contact those accounts and advise them of the recall situation, and have them return their outstanding recalled stocks. If customers have any questions, they were instructed to contact at 858-481-8485.

Device

Device Recall Bionime Rightest Blood Glucose Monitoring System
  • Modelo / Serial
    Lot Numbers: 1FF19C0001 to 1FF19C0020,  1FF05C0001 to 1FF05C5000,  2FH15C0001 to 2FH15C4800,  230GBB0001 to 230GBB0050, 230GFF0001 to 230GFF0600, 230GFF0601 to 230GFF1200, 230GFF1201 to 230GFF1996, 230GHC0001 to 230GHC3204, 230GHC3205 to 230GHC4204, 230GHJ0001 to 230GHJ5000, 230GHJ5001 to 230GHJ6992, and 230GIB0001 to 230GIB3008
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution
  • Descripción del producto
    Invictus-- Bionime Rightest Blood Glucose Monitoring System || MODEL: GM300; Invictus Scientific, Inc., San Diego, CA
  • Manufacturer
    Invictus Scientific Inc

Manufacturer

Invictus Scientific Inc
  • Dirección del fabricante
    Invictus Scientific Inc, 11760 Sorrento Valley Rd, Ste G, San Diego CA 92121
  • Source
    USFDA