Events

Recall of Device Recall PLAC Test Calibrator 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
    51215
  • Event Risk Class
    Class 2
  • Event Number
    Z-1205-2009
  • Event Initiated Date
    2009-02-09
  • Event Date Posted
    2009-04-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-01-05
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=79237
  • 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
    Lipoprotein-Associated Phosphlipase A2 Immunoassay Test System - Product Code NOE
  • Reason
    Premature expiration-- the product is projected to fall short of expected shelf life, and may result in inaccurate results.
  • Action
    Distributors and Direct accounts were notified by phone followed by Notification letter and certificate of destruction via FedEx. International customers were notified via e-mail with PDF copies of notices, to be followed by hard copies via FedEx. Customers are requested to record the number of kits (full and partial ) they had on the Certificate of Destruction and to dispose of that number of kits with two people signing the form, and then to fax that form to diaDexus.

Device

Device Recall PLAC Test Calibrator Kit
  • Model / Serial
    lot number 048091, expiration date 2009-09.
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution
  • Product Description
    PLAC Test Calibrator Kit, Five-level liquid calibrator set for use with the diaDexus PLAC Test Reagent Kit, assembled in a kit box with an outer label, Catalog numbers 90108 and 10-0108, manufactured by diaDexus inc., South San Francisco, CA. || Intended to establish points of reference that are used in the determination of values in the determination of Lp-PLA2 by the PLAC Test Reagent Kit.
  • 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