Events

Recall of Device Recall PLAC Test ELISA Kit

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by DiaDexus, Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    56017
  • Event Risk Class
    Class 2
  • Event Number
    Z-0429-2011
  • Event Initiated Date
    2010-03-15
  • Event Date Posted
    2010-11-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-01-11
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=92430
  • Notes / Alerts
    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.
  • Extra notes in the data
    Test, system, immunoassay, lipoprotein - associated phospolipase a2 - Product Code NOE
  • Reason
    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
  • Model / Serial
    Lot Number: 907090; Part Number: 90123; Product Code NOE
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution - US including NJ, OH, KS, IN, FL, CA, UT, OK, PA, WA and MI.
  • Product Description
    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
  • Manufacturer Address
    DiaDexus, Inc, 343 Oyster Point Blvd, South San Francisco CA 94080
  • Manufacturer Parent Company (2017)
    DiaDexus, Inc
  • Source
    USFDA