Events

Recall of PLAC Test Reagent Kit, immunoturbidimetric method

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
    53856
  • Event Risk Class
    Class 2
  • Event Number
    Z-1749-2010
  • Event Initiated Date
    2009-10-29
  • Event Date Posted
    2010-06-03
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-01-26
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=86703
  • 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 phospholipase a2 - Product Code NOE
  • Reason
    Inaccurate results-- some samples may return with falsely elevated results potentially as a result of an interfering substance. some patients may be subjected to additional lifestyle changes or intensified pharmaceutical therapy; such as statins, as a result of the falsely elevated result.
  • Action
    Notification letter issued to consignees on 10/29/2009. Customers were instructed to not report PLAC test results for samples that are greater than 360 ng/mL, and pursue confirmatory testing by contacting DiaDexus. Customers with questions please call the company technical support line toll free at 1-877-752-2837 for assistance. UPDATE: On April 30, the firm suspended marketing of the PLAC TIA method, as the limited range no longer covered the clinical data/reference range data cited in the product insert. The firm sent out a letter notifying customers on May 10, 2010. The firm set up a sample send out program, so that customers can send samples to labs running the ELISA method PLAC test. Arrangements were made so that labs could be enabled to run a CLIA complex assay, for customer credit programs for un-used products, and a fax back response form for response tracking.

Device

PLAC Test Reagent Kit, immunoturbidimetric method
  • Model / Serial
    Lot numbers 078011, 088061, 098091, 109011, 119021, 129031, 139051, 139051A
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Product was distributed to 123 consignees throughout the US.
  • Product Description
    PLAC Test Reagent Kit, immuno-turbidimetric method, Part Number 10-112, 10-0113, and 10-115 Advia test kit, manufactured by DiaDexus, South San Francisco, CA.
  • 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