Retiro De Equipo (Recall) de Device Recall IDkit:HP" Two Test 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 Exalenz Bioscience Ltd.

¿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
    59891
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0042-2012
  • Fecha de inicio del evento
    2011-06-07
  • Fecha de publicación del evento
    2011-10-12
  • Estado del evento
    Terminated
  • País del evento
  • Fecha de finalización del evento
    2012-07-06
  • 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
    Test, urea (breath or blood) - Product Code MSQ
  • Causa
    The product is in violation of the fd&c; act in that it was illegally marketed without proper clearance (no 510(k) submitted).
  • Acción
    The firm, Exalenz Bioscience Ltd. notified consignees located in the United States of the recall by telephone, electronic mail, or written correspondence between June 9, 2011 and June 30, 2011. The letter informed consignees that Exalenz will immediately cease marketing the IDkit:HP TWO test in the United States. Consignees were instructed to return shipment of the IDkit:HP TWO test kits that they have in their possession to the companys US warehouse. For question call the VP of North American Sales at 704-770-6162 or VP of Marketing at 617-794-6936.

Device

  • Modelo / Serial
    Reorder No. AC00028, Lot numbers: 11-071, 11-0561, 10-00018 and 10-00017.
  • Clasificación del producto
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution (USA) - including the states of: FL, IL, LA, MA, MS, NY, TN, TX and VA.
  • Descripción del producto
    IDkit:HP" Breath Test for Detection of H. pylori, Manufactured by: Exalenz Bioscience Ltd 4 Ha' maayan St. Modiin, Israel 71700, Distributed by: Exalenz Bioscience Inc., 1313 N. Market St., Sute 5100, Wilmington, DE 19808 USA || Product Usage: The IDkit:HP Two Test System is intended for use in the qualitative detection of urease associated with Helicobacter pylori in the human stomach and as an aid in initial diagnosis and post treatment monitoring of H. pylori infection in adult patients. Urea Breath Tests are well established as reliable, non-invasive methods for detecting H. pylori. They are highly endorsed by various medical societies as the test of choice for initial detection as well as for post-treatment testing.
  • Manufacturer

Manufacturer

  • Dirección del fabricante
    Exalenz Bioscience Ltd, Hamaayan 4, Modiin Israel
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA