Events

Retiro De Equipo (Recall) de Device Recall AxSYM Drugs of Abuse/Toxicology Assay Disk Version 8.0

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
    46740
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-1462-2008
  • Fecha de inicio del evento
    2008-01-21
  • Fecha de publicación del evento
    2008-05-14
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2009-12-01
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=68116
  • 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
    Amphetamine test system - Product Code DKZ
  • Causa
    Error message: if the positive and negative interpretation cutoff parameters (116/117) are edited after installation of the revised assay file, vrtx error #0002 in task 40 is generated and the instrument locks up when it attempts to report an axsym amphetamine/methamphetamine ii patient result.
  • Acción
    Consignees were sent a Product Correction-Immediate Action Required letter on 1/21/08. The letter provided users with the steps to take to temporarily correct the problem until the recalling firm is able to send a corrected assay file. Users were requested to return a customer reply letter acknowledging receipt of the letter. For additional information, contact 1-877-4ABBOTT.

Device

Device Recall AxSYM Drugs of Abuse/Toxicology Assay Disk Version 8.0
  • Modelo / Serial
    Lot Numbers: 59311P100 and 59312P100.
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution including USA territory of Puerto Rico, and countries of Australia, Canada, Chile, Colombia, Germany, Mexico, New Zealand, South Korea, Taiwan, Thailand and Venezuela.
  • Descripción del producto
    AxSYM Drugs of Abuse/Toxicology Assay Disk Version 8.0; List Number: 3D54-08; Abbott La boratories, Diagnostics Division, Abbott Park, IL 60064
  • 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