Events

Retiro De Equipo (Recall) de Alere Cholestech LDX Analyzer and Alere Cholestech Lipid Profile

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
    74940
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-2778-2016
  • Fecha de inicio del evento
    2016-08-02
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-10-28
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=148868
  • 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
    Ldl & vldl precipitation, cholesterol via esterase-oxidase, hdl - Product Code LBS
  • Causa
    Incorrect expiration date on the magnetic strip that does not match the labeled expiration date.
  • Acción
    Alere issued a recall notification to customers via telephone and email. Customers was informed of the affected product, problem and actions to be taken. Customers were instructed if they have the affected lot contact the Alere technical service department at 877-308-8289 to report this lot and receive a free replacement. For questions call 877-308-8289 and reference their specific case number.

Device

Alere Cholestech LDX Analyzer and Alere Cholestech Lipid Profile
  • Modelo / Serial
    Model Number: 10-228 and 14-535 Lot Number: 332994
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - U.S Nationwide in the states of: TN, MA, GA, OK, VA, FL, TN, MO, AL, TX, IL, NY, VT, RI, KY, WI, AL, NC, LA, SD, TX, VA, MI, MN, IN, IA, CA, AR, PA, HI, WV, KS, CO, CT, UT and the countries of Japan, England, Canada
  • Descripción del producto
    LDX Optical Check Cassettes (OCC) || Model Number: 10-228 and 14-535 || Cassette in box with foam insert. The cassette is used to check the optics system of the LDX analyzer. || Product Usage: || The Optics Check Cassette is used to check the optics system of the Alere Cholestech LDX¿ Analyzer. It is run once a day before patient samples are tested and after the analyzer has been moved or serviced.
  • 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