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
    37952
  • Event Risk Class
    Class 3
  • Event Number
    Z-1072-2007
  • Event Initiated Date
    2007-05-08
  • Event Date Posted
    2007-08-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-10-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=52336
  • 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
    in vitro diagnostic - Product Code GGP
  • Reason
    Specific lots of sta liatest free protein s may result in low results in the assigned value ranges and sometimes outside the lower limit.
  • Action
    Customers were sent a Product Recall Notification on May 8, 2007 by first class mail labeled " Recall notice, Open Immediately"

Device

Device Recall STA Liatest
  • Model / Serial
    Catalog number: 0516 Lot Numbers: 061312, Exp 5/31/07;  061991, Exp 8/31/07;  062633, Exp 10/31/07;  063281, Exp 12/31/07
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Medical facilities nationwide
  • Product Description
    STA Liatest Free Protein S || For in vitro diagnostic use. || 2-8 degrees C || Distributed in the USA by: || Diagnostica Stago, Inc. || 5 Century Drive || Parsippany, NJ || Phone 800-abc coag || 1 - 6 x 5 ml Buffer || 2 - 6 x 6 ml Latex
  • Manufacturer
    Diagnostica Stago, Inc.

Manufacturer

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