Events

Retiro De Equipo (Recall) de Device Recall diaDexus PLAC Test Reagent Kit

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 DiaDexus, 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
    50482
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1204-2009
  • Fecha de inicio del evento
    2008-11-04
  • Fecha de publicación del evento
    2009-04-01
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2009-12-21
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=75467
  • 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
    Lipoprotein-associated phospholipase a2 Immunoassay Test System - Product Code NOE
  • Causa
    Storage equipment failure at distributor site due to hurricane ike caused product to experience a temperature variation and go out of range. the integrity of the product could not be assured.
  • Acción
    The firm and its distributor contacted the consignees via phone on 11/04/08. The firm informed them of the issue and inquired about the products' status. An Urgent: Device Recall letter was issued on 11/04/08 via FedEx. The letter requested that use of the kit be immediately discontinued and returned promptly. A phone call was made to follow up requesting return of the product.

Device

Device Recall diaDexus PLAC Test Reagent Kit
  • Modelo / Serial
    sub lot of lot 088061, expiration date 2008-12
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution
  • Descripción del producto
    diaDexus Inc. PLAC Test Reagent Kit, Turbidimetric Immunoassay for the Quantitative Determination of Lp-PLA2 in Human Plasma or Serum, liquid ready-to-use two-reagent kit assembled in a kit box, manufactured by diaDexus Inc, South San Francisco, CA 94080, Catalog number 90110 || Turbidimetric Immunoassay for the Quantitative Determination of Lp-PLA2 in Human Plasma or Serum on automated clinical chemistry analyzers, to be used in conjunction with clinical evaluations and patient risk assessment as an aide in predicting risk for coronary heart disease, and ischemic stroke associated with atherosclerosis.
  • Manufacturer
    DiaDexus, Inc

Manufacturer

DiaDexus, Inc
  • Dirección del fabricante
    DiaDexus, Inc, 343 Oyster Point Blvd, South San Francisco CA 94080
  • Empresa matriz del fabricante (2017)
    DiaDexus, Inc
  • Source
    USFDA