Events

Retiro De Equipo (Recall) de Device Recall PLAC Test ELISA 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
    56017
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0429-2011
  • Fecha de inicio del evento
    2010-03-15
  • Fecha de publicación del evento
    2010-11-22
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-01-11
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=92430
  • 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
    Test, system, immunoassay, lipoprotein - associated phospolipase a2 - Product Code NOE
  • Causa
    The reason for the recall is that real time stability test program showed the kit lot failed stability prior to expiration, affecting samples with results> 500 ng/ml. results up to 500 ng/ml exhibit passing stability results and are not impacted by this issue.
  • Acción
    DiaDexus notified all customers by phone, including distributor's customers, beginning on March 15, 2010. Customers were told to re-test samples that were tested from 2/1/2010 through 2/28/2010 which have values above 500 ng/ml with a new lot of product. For questions regarding this recall call (650) 246-6477.

Device

Device Recall PLAC Test ELISA Kit
  • Modelo / Serial
    Lot Number: 907090; Part Number: 90123; Product Code NOE
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution - US including NJ, OH, KS, IN, FL, CA, UT, OK, PA, WA and MI.
  • Descripción del producto
    diaDexus PLAC Test ELISA Kit; Manufactured and distributed by diaDexus , Inc., South San Francisco, CA; Model Part Number: 90123 || The diaDexusPLAC Test ELISA Kit is an enzyme Immunoassay for the quantitative determination of Lp-PLA2 (lipoprotein-associated phospholipase A2) in human plasma and serum, to be used in conjunction with clinical evaluation and patient risk assessment as an aid in predicting risk for coronary hear 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