Events

Retiro De Equipo (Recall) de ARCHITECT STAT TroponinI Reagent Kit

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 Laboratories.

¿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
    61630
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1509-2012
  • Fecha de inicio del evento
    2012-04-11
  • Fecha de publicación del evento
    2012-05-10
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-12-23
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=108593
  • 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
    The lot of troponin-i is demonstrating a shift in expected results in some cases, and varies from kit to kit. a concentration change of up to +/-55% could occur when switching kits without recalibrating.
  • Acción
    The firm, Abbott Laboratories, sent a "Product Recall Immediate Action Required"letter dated April 11, 2012 to all Troponin-I customers who received the affected reagent lot internationally. The customers were directed to determine if they are currently using and/or have inventory of lot 74264UN11; to discontinue use and destroy any remaining inventory of the lot; to follow their facility's policies and procedures for communicating with the heath care providers they serve; to forward a copy of the letter to any laboratory to whom they may have forwarded the reagent; to retain a copy of the letter for their records and to complete and return the Customer Reply Form (sent to Abbott international affiliates via e-mail on 4/11/2012) via fax to: 1-800-777-0051 or e-mail: QAGCO@abbott.com. Any questions were directed to their local Customer Service representative or call the field action coordinator at 847-938-1923 or email: albert.chianello@abbott.com.

Device

ARCHITECT STAT TroponinI Reagent Kit
  • Modelo / Serial
    list number 2K41-28, lot number 74264UN11, expiration date 31OCT12
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    International distribution only: including countries of: Algeria, Argentina, Australia, Austria, Bangladesh, Belgium, Bosnia & Herze, Brazil, Bulgaria, Canada, Chile, China, Columbia, Croatia, Cyprus, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Kazakhstan, Kuwait, Latvia, Lebanon, Lithuania, Luxembourg, Macedonia, Mali, Malaysia, Mauritania, Mexico, Morocco, Netherlands, New Zealand, Norway, Oman, Pakistan, Paraguay, Poland, Portugal, Romania, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Tunisia, Turkey, United Arab Emirates, United Kingdom, Venezuela and Vietnam.
  • Descripción del producto
    ARCHITECT STAT Troponin-I Reagent Kit; list numbers 2K41-28 (500 test kit); an in-vitro diagnostic test kit; each kit contains bottles of microparticles, conjugate and assay diluent; Abbott Laboratories, Abbott Park, IL 60064 || ARCHITECT STAT Troponin-I is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of cardiac troponin-I in human serum and plasma on the ARCHITECT i System with STAT protocol capability. Troponin-I values are used to assist in the diagnosis of myocardial infarction (MI) and in the risk stratification of patients with acute coronary syndromes (including unstable angina and non-ST elevation) with respect to relative risk of mortality, myocardial infarction, or increased probability of ischemic events.
  • Manufacturer
    Abbott Laboratories

Manufacturer

Abbott Laboratories
  • Dirección del fabricante
    Abbott Laboratories, 100 Abbott Park Rd, Abbott Park IL 60064-3502
  • 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