Events

Recall of Device Recall STA Liatest

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Diagnostica Stago, 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
    37746
  • Event Risk Class
    Class 2
  • Event Number
    Z-0853-2007
  • Event Initiated Date
    2007-03-13
  • Event Date Posted
    2007-07-03
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-01-16
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=51450
  • 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
    Von Willebrand Factor-Immuno-Turbidimetric Assay - Product Code GGP
  • Reason
    A dose-hook effect is observed starting from vwf:ag levels of 300%, while the package insert indicates that no dose-hook effect has been observed with vwf:ag levels up to 800%.
  • Action
    Customers were notified on March 13, 2007 by letter, first class mail.

Device

Device Recall STA Liatest
  • Model / Serial
    Lot -- Exp:  052783 -- April 2007; 061242 -- November 2007; 061981 -- February 2008.
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Hospitals and laboratories Nationwide
  • Product Description
    STA Liatest VWF:Ag, Product Catalog Number : 0518. This is a Immuno-Turbidimetric Assay of von Willebrand Factor.
  • Manufacturer
    Diagnostica Stago, Inc.

Manufacturer

Diagnostica Stago, Inc.
  • Manufacturer Address
    Diagnostica Stago, Inc., 5 Century Dr, Parsippany NJ 07054-4607
  • Source
    USFDA