Events

Rappel de Device Recall PLAC Test ELISA Kit

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par DiaDexus, Inc.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    56017
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0429-2011
  • Date de mise en oeuvre de l'événement
    2010-03-15
  • Date de publication de l'événement
    2010-11-22
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2011-01-11
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=92430
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Test, system, immunoassay, lipoprotein - associated phospolipase a2 - Product Code NOE
  • Cause
    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.
  • Action
    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
  • Modèle / numéro de série
    Lot Number: 907090; Part Number: 90123; Product Code NOE
  • Classification du dispositif
    Immunology and Microbiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution - US including NJ, OH, KS, IN, FL, CA, UT, OK, PA, WA and MI.
  • Description du dispositif
    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
  • Adresse du fabricant
    DiaDexus, Inc, 343 Oyster Point Blvd, South San Francisco CA 94080
  • Société-mère du fabricant (2017)
    DiaDexus, Inc
  • Source
    USFDA