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
    56639
  • Event Risk Class
    Class 2
  • Event Number
    Z-1737-2011
  • Event Initiated Date
    2010-08-20
  • Event Date Posted
    2011-03-21
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-03-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=94160
  • 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 Phospholipase A2 Immunoassay Test System - Product Code NOE
  • Reason
    Product fails stability tests prior to expiration date.
  • Action
    A phone script has been prepared to contact customers. Customers were informed of the affected product and its reason for the recall. If customers didn't use the product after May 11, 2010, the action is considered complete. If the product was used after May 11, 2010, a follow up letter will be sent to the customer and they will be asked to re-test any samples beyond May 11, 2010 with an alternate lot of reagent.

Device

Device Recall PLAC Test ELISA Kit
  • Model / Serial
    Lot number 910013, expiration date 05/31/2010
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- US, including states of UT, OH, CA, NJ, NC, FL, OK, MA, NY, TX, NJ, WA, and MI and countries of Germany and Israel.
  • Product Description
    diaDexus PLAC Test ELISA Kit, Enzyme Immunoassay for Quantitative Determination of Lp-PLA2 in human plasma or serum, part number 90123, manufactured by diaDexus Inc, South San Francisco.
  • 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