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
    49044
  • Event Risk Class
    Class 2
  • Event Number
    Z-2400-2008
  • Event Initiated Date
    2008-07-18
  • Event Date Posted
    2008-09-26
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-12-22
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=72583
  • 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
    Immunoassay test system - Product Code NOE
  • Reason
    Product may give lp-pla2 values at up to 22% lower than accurate values.
  • Action
    All customers received communication of product correction dated July 18. 2008, via Federal Express, which included a cover letter, technical bulletin, specimen handling best practices cards, and revised package inserts. E-mail communication was also sent to all but seven customers. Contact diaDexus Technical Support at 1-877-752-2837 for assistance.

Device

Device Recall PLAC Test ELISA Kit
  • Model / Serial
    All lots
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US, OUS: UK and Germany.
  • Product Description
    PLAC Test ELISA kit, catalog number 90106, enzyme immunoassay for the quantitative determination of Lp-PLA2 in human plasma and serum, kit containing coated microwell stripplate and reagents (12 strips, 1 set calibrators 1 to 6, 0.25 ml each, 20x wash buffer, 50 mL, conjugate 23 mL, TMB, 11 mL, Stop solution, 11 mL
  • Manufacturer
    DiaDexus, Inc

Manufacturer

DiaDexus, Inc
  • Manufacturer Address
    DiaDexus, Inc, 343 Oyster Point Blvd, South San Francisco CA 94080-1913
  • Manufacturer Parent Company (2017)
    DiaDexus, Inc
  • Source
    USFDA