Events

Retiro De Equipo (Recall) de Abbott iSTAT PT/INR 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
    66757
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0451-2014
  • Fecha de inicio del evento
    2013-10-28
  • Fecha de publicación del evento
    2013-12-04
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-05-29
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=123293
  • 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, time, prothrombin - Product Code GJS
  • Causa
    Abbott point of care inc (apoc) has determined that i-stat pt/inr cartridges have the potential to exhibit incorrectly elevated inr.
  • Acción
    Abbott Point of Care Inc. (APOC) issued an Urgent Recall Notice on October 28, 2013, to all affected 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 PT/INR lots in this letter. All unused cartridges would be credited and are to be returned as instructed on the enclosed Business Reply Card. If customers provided cartridges from the lot number listed above to another institution they were instructed to provide a copy of this letter to them. Customers with questions were instructerd to contact Abbott Point of Care Technical at 1-800-366-8020, Option 1. For questions regarding this recall call 800-366-8020.

Device

Abbott iSTAT PT/INR cartridges
  • Modelo / Serial
    K020355  List number 04J50-01, 04J50-02; 03P89-24  Lot number R13149A; R13151; R13151A and cartridge lots from C13139 up to and including C13270A
  • Clasificación del producto
    Hematology and Pathology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA (nationwide) and Internationally to Argentina, Australia, Brazil, Chile, China, Finland, France, Germany, Greece, Hong Kong, Ireland, Italy, South Korea, Kuwait, Mexico, Netherland, New Zealand, Nigeria, Peru, Poland, Portugal, Qatar, Russia, Saudi Arabia, Singapore, south Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, UAE, and United Kingdom,
  • Descripción del producto
    Abbott i-STAT PT/INR cartridges Abbott Point of Care Inc., Princeton, NJ 08540 || The i-Stat PT a prothrombin time test is useful for monitoring patients receiving oral anticoagulation therapy such as Coumadin or Warfarin. The cartridge is to be used with the i-Stat 1 Analyzer and as part of the i-Stat System, the PT/INR test is to be used by trained health care professionals in accordance with a facility's policies and procedures.
  • 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