Events

Recall of STA Liatest Free Protein S, cat. 00516.

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
    34011
  • Event Risk Class
    Class 3
  • Event Number
    Z-0408-06
  • Event Initiated Date
    2005-10-26
  • Event Date Posted
    2006-01-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-03-01
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=42903
  • 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, Qualitative And Quantitative Factor Deficiency - Product Code GGP
  • Reason
    The mean levels (%) of normal and abnormal control plasmas (sta liatest control n and p) obtained with sta liatest free protein s are found in the lower part of the range.
  • Action
    Notification via recall letter was sent out on 10/26/2005. The letter was unsatisfactory and the letter was resent on 11/10/2005 as a recall letter.

Device

STA Liatest Free Protein S, cat. 00516.
  • Model / Serial
    Lot 0422671 exp. March 2006.
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Product was distributed to 23 direct account customers nationwide.
  • Product Description
    STA Liatest Free Protein S, cat. 00516. These kits are intended for use with analyzers of the STA brand name for the quantitative determination of free protein S in plasma by the immuno-turbidimetric method.
  • Manufacturer
    Diagnostica Stago, Inc.

Manufacturer

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