Events

Retiro De Equipo (Recall) de iSTAT ACT Kaolin Cartridges

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 Abbott Point Of Care 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
    57005
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0400-2011
  • Fecha de inicio del evento
    2010-10-06
  • Fecha de publicación del evento
    2010-11-17
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-08-22
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=95163
  • 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
    Activated whole blood clotting time - Product Code JBP
  • Causa
    Certain lots of i-stat celite act and kaolin act cartridges may be difficult to fill or will not fill when attempting to transfer blood to the sample entry port of the cartridge.
  • Acción
    Abbott Point of Care, Inc. sent an URGENT RECALL NOTICE dated September 2010 on October 6, 2010 by Federal Express to all US customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to discontinue use of cartridges from the identified lots. If customers did not currently have replacement cartridges then they should continue to use the cartridge lot until their facility receives replacement material. Upon receipt of replacement material, customers were to discontinue use of and return the affected cartridges and switch to the replacement material. All unused cartridges will be credited and will be returned. If you have any questions regarding this information, please contact Abbott Point of Care Technical Support at 800-366-8020, Option 1 or your Abbott Point of Care representative.

Device

iSTAT ACT Kaolin Cartridges
  • Modelo / Serial
    List numbers: 07G81-01, 07G81-02; Lot numbers: S10129, S10129A, S10130, S10130B, S10147A, S10147B, S10147C, S10147D, S10147E, S10148A, S10148B, S10148C, S10148D, S10148G, S10149, S10149B, S10149C, S10151A, S10151B, S10152, S10152A, S10152B, S10152C, S10152D, S10152E, S10152F, S10154A, S10154B, S10154D, S10160B, S10162.
  • Clasificación del producto
    Hematology and Pathology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution
  • Descripción del producto
    i-STAT ACT Kaolin Cartridges || in vitro diagnostic test which uses fresh whole blood to monitor high-dose heparin anticoagulation frequently associated with cardiovascular surgery.
  • Manufacturer
    Abbott Point Of Care Inc.

Manufacturer

Abbott Point Of Care Inc.
  • Dirección del fabricante
    Abbott Point Of Care Inc., 400 College Rd E, Princeton NJ 08540-6607
  • Empresa matriz del fabricante (2017)
    Abbott Laboratories
  • Comentario del fabricante
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    USFDA