Events

Retiro De Equipo (Recall) de Alere Cholestech LDX Lipid Profile"GLU Test Cassette

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
    66663
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-0379-2014
  • Fecha de inicio del evento
    2013-10-23
  • Fecha de publicación del evento
    2013-11-22
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-09-25
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=122917
  • 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
    Glucose oxidase, glucose - Product Code CGA
  • Causa
    Alere initiated a recall of cholestech ldx lipid profile-glu test cassettes, catalog number 10-991, lot # 320167, becuase an incorrect lot number was printed on the outer 10 pack kit box label. the incorrect lot # number printed was 321067.
  • Acción
    Alere initiated this recall by sending out notification letters to customers via fax, email, or direct mail. The letter titled "URGENT MEDICAL DEVICE NOTICE", dated October 23, 2013 is accompanied by a response form/Verification form. The notification informed customers of the reason for recall, product description with codes, required actions by the customers, and contact information.

Device

Alere Cholestech LDX Lipid Profile"GLU Test Cassette
  • Modelo / Serial
    Model Number: 10-991.  Lot #320167. Expiration date, or Expected shelf life: 8/31/14. Expected shelf life: up to 12 months.
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution: USA (nationwide) and Internationally to Canada.
  • Descripción del producto
    Product Brand Name(s): Alere Cholestech LDX¿ Lipid Profile"GLU Test Cassette, Model 10-991. || Product Generic Name: Alere Cholestech LDX¿ Lipid Profile"GLU Test Cassette. || Description of the product: Lipid. Glucose panel Test cassettes. || Product packaging: 10 individually pouched cassettes in a labeled kit box. || Intended for the quantitative determination of total cholesterol, HDL (high-density lipoprotein) cholesterol, triglycerides, and/or glucose in whole blood, serum, and plasma.
  • 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