Retiro De Equipo (Recall) de Cholestech GDX A1C Test Cartridge

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 Cholestech Corp.

¿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
  • ID del evento
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
  • Fecha de inicio del evento
  • Fecha de publicación del evento
  • Estado del evento
  • País del evento
  • Fecha de finalización del evento
  • Fuente del evento
  • URL de la fuente del evento
  • 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
    Cartridge - Product Code LCP
  • Causa
    Cholestech corp. was notified by the foreign manufacturer of the a1c test cartridge that stability data indicated that the product would not meet performance claims through the end of its shelf life.
  • Acción
    A customer notification letter was sent to Cholestech consignees who had received product from this lot. The letter dated 8/3/2006 instructed customers to discontinue use of the lot of product, destroy product according to in-house standard procedures and contact Cholestech Technical Services for replacement. It also instructed to provide a copy of the letter to other users if the lot of product was further distributed. A response form was included with instructions to complete and return. Contact Cholestech Corp at 1-510-781-3505 for assistance.


  • Modelo / Serial
    Catalog #12-658, Lot #066T28
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    U.S. state of Colorado. OUS: India, Slovenia, Germany, Tunisia, Taiwan, Canada, Philippines, South Africa and Mexico
  • Descripción del producto
    Cholestech GDX A1C Test Cartridge. The Cholestech GDX A1C Test is an in-vitro diagnostic test that measures hemoglobin A1c (HbA1c).
  • Manufacturer


  • Dirección del fabricante
    Cholestech Corp, 3347 Investment Blvd, Hayward CA 94545-3808
  • Empresa matriz del fabricante (2017)
  • 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