Events

Retiro De Equipo (Recall) de Device Recall Alere Cholestech LDX hsCRP 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
    64701
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1178-2013
  • Fecha de inicio del evento
    2013-03-06
  • Fecha de publicación del evento
    2013-04-25
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-03-12
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=116831
  • 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
    C-reactive protein, antigen, antiserum, and control - Product Code DCK
  • Causa
    The alere cholestech ldx¿ hscrp cassette (pn 12-807) may have increased imprecision relative to the performance data in the package insert, which may cause differences in quantitative results for hscrp compared to a reference method or repeat testing on the same patient sample.
  • Acción
    Alere sent an Urgent Medical Device Recall letter dated March 6, 2013 to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to block all stock of the affected lot in their warehouses; discontinue use and discard all stock on hand, complete the provided Customer Verification form to document disposal, contact their primary consignees and advise them of the required discontinuation and disposal of the affected lot. For question call 877-308-8289.

Device

Device Recall Alere Cholestech LDX hsCRP Test Cassette,
  • Modelo / Serial
    Model Number 12-807. ¿ Lot/Unit Codes: 274632, 281847 ¿ Expiration date, or Expected shelf life: 5/5/13, 6/30/13
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    USA Nationwide Distribution
  • Descripción del producto
    The Alere Cholestech LDX¿ high sensitivity C-Reactive Protein (hsCRP) Test Cassette, Model Number 12-807. || Product Usage: || Immunoassay for the determination of C-Reactive Protein (CRP). The Alere Cholestech LDX¿ high sensitivity C-Reactive Protein (hsCRP) is an in vitro diagnostic test for the quantitative determination of C-reactive protein in whole blood or serum.
  • 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