Events

Retiro De Equipo (Recall) de Device Recall AxSYM System Tubing Decontamination Solution

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
    51258
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-2317-2009
  • Fecha de inicio del evento
    2009-02-18
  • Fecha de publicación del evento
    2009-09-30
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2010-07-08
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=79482
  • 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
    Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
  • Causa
    Bottle labels from lot 211974, axsym system tubing decontamination solution (list number 7b05-09), were found to be missing the following information: lot number, date of manufacture, and expiration date.
  • Acción
    Abbott sent Product Recall Immediate Action Required letters dated February 18, 2009 to customers informing them of the affected product. Customers were instructed to examine their inventory and dispose all affected product. Accounts were requested to complete and fax back customer reply sheet acknowledging receipt of the letter, as well as the number of bottles destroyed, and to retain a copy of the letter for their records. For further information, contact Abbott Customer Service at 1-877-4ABBOTT.

Device

Device Recall AxSYM System Tubing Decontamination Solution
  • Modelo / Serial
    List 7B05-09, Lot Number: 211974, expiration date 9/30/09.
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution -- United States including Puerto Rico and Argentina, Brazil, Canada, Chile, Columbia, Germany, Hong Kong, Japan, Mexico, Peru, South Korea, Thailand and Trinidad & Tobago.
  • Descripción del producto
    AxSYM System Tubing Decontamination Solution; 500 mL bottle; Abbott Laboratories, Diagnostics Division, Abbott Park, IL 60064; List Number 07B05-09. || To be used only for cleaning and inhibition of fouling bacteria in the tubing system of the in vitro immunoassay analyzer. This product does not disinfect or sterilize the tubing system.
  • 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