Events

Retiro De Equipo (Recall) de Device Recall Cardiac Marker Test

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 Alere San Diego, 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
    68230
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1727-2014
  • Fecha de inicio del evento
    2014-05-02
  • Fecha de publicación del evento
    2014-06-06
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-02-27
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=127185
  • 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
    Fibrin split products - Product Code GHH
  • Causa
    Alere initiated this recall because a limited number of alere triage¿ d-dimer devices from pn 98100 lot w53884b were incorrectly manufactured. as a result, when testing patient sample these affected devices will either generate an error code (e.G. e4 error), or they may generate an incorrect result.
  • Acción
    Alere sent an Urgent Medical Device Recall letter dated May 2, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers are instructed to stop using all product from the affected lot, lot W53884B, and to discard any unused product. The customers were also instructed to complete and return the verification form indicating any credit or replacement product requested. They were also instructed to contact their primary consignees and advise them of the notice. Should you have any questions about the information contained in this notification, please call (877) 308-8287. and /or email:Triage.Support@alere.com

Device

Device Recall Cardiac Marker Test
  • Modelo / Serial
    PN 98100, Lot W53884B.
  • Clasificación del producto
    Hematology and Pathology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution only.
  • Descripción del producto
    Alere Triage¿ D-Dimer Test || PN 98100, Lot W53884B. || The Alere Triage¿ D-Dimer Test is a fluorescence immunoassay to be used with the Alere Triage¿ Meters for the quantitative determination of cross-linked fibrin degradation products containing D-dimer in EDTA anticoagulated whole blood and plasma specimens. || . || The Alere Triage¿ D-Dimer test is intended for use as an aid in the assessment and evaluation of patients suspected of having disseminated intravascular coagulation or thromboembolic events including pulmonary embolism.
  • Manufacturer
    Alere San Diego, Inc.

Manufacturer

Alere San Diego, Inc.
  • Dirección del fabricante
    Alere San Diego, Inc., 9975 Summers Ridge Rd, San Diego CA 92121-2997
  • 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