Events

Retiro De Equipo (Recall) de Device Recall iSTAT cTnI 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
    62410
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2237-2012
  • Fecha de inicio del evento
    2012-03-07
  • Fecha de publicación del evento
    2012-08-22
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-02-19
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=110437
  • 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
    Immunoassay method, troponin subunit - Product Code MMI
  • Causa
    Abbott point of care has determined that i-stat ctnl cartridges have the potential to exhibit incorrectly elevated cardiac troponin i results. this recall was expanded on july 19 2012 to include additional information regarding user documentation.
  • Acción
    Abbott Point of Care (APOC) sent an Urgent Recall Notice letters, via Fed Ex on March 07, 2012 to all affected customers. APOC sent an important product information update on July 19, 2012 to all of their affected customers. The letter identified the affected product, problem and actions to be taken. Customers are asked to review the information included as it may pertain to their cartridges. Customers were instructed that if the affected product have been forwarded to another facility, provide a copy of this letter to them. For additional information, contact APOC at 800-366-8020 option 1 or your Abbott Point of Care representative.

Device

Device Recall iSTAT cTnI cartridges
  • Modelo / Serial
    510(K)K031739 List Number 06F15-03, 06F15-04, 03P90-25, 600-9009-25  All lots
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US Nationwide, International
  • Descripción del producto
    i-STAT cTnI cartridges || Product Usage: || The i-STAT cTnl test is an in vitro diagnostic test for the quantitative measurement of cardiac troponin I in heparinized whole blood or plasma samples. Cardiac I troponin measurement cane be used as an aid in the diagnosis and treatment of myocardial infarction and in the risk stratification of patients with acute coronary syndromes with respect to their relative risk of mortality.
  • 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