Events

Recall of Device Recall STA

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
    37834
  • Event Risk Class
    Class 3
  • Event Number
    Z-0979-2007
  • Event Initiated Date
    2007-03-30
  • Event Date Posted
    2007-07-03
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-11-30
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=51801
  • 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 GJS
  • Reason
    Based on the confirmed clotting times in the upper part of the assigned ranges of sta-coag control abn control plasmas when used with sta-neoplastine ci plus, use of this lot may cause difficulty during the validation of the sta-coag control abn.
  • Action
    Recall notification letters were sent on March 30, 2007 by first class mail. The letter advises customers that lot 061781 of STA-Neoplastine Cl Plus may cause difficulty during the vailidation process of STA-Coag Control ABN control plasmas, and asks that the lot number be discontinued.

Device

Device Recall STA
  • Model / Serial
    Lot 061781, June 2008
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide.
  • Product Description
    STA Neoplastine CI Plus (10), (cat. 0667). || 12 x 10 ml. in vitro diagnostic for the determination of prothrombin time (PT).
  • Manufacturer
    Diagnostica Stago, Inc.

Manufacturer

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