Events

Recall of Device Recall Diagnostica Stago Inc.

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
    64320
  • Event Risk Class
    Class 2
  • Event Number
    Z-0951-2013
  • Event Initiated Date
    2013-01-28
  • Event Date Posted
    2013-03-14
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-07-19
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=115819
  • 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
    Plasma, coagulation factor deficient - Product Code GJT
  • Reason
    Diagnostica stago has confirmed that sometimes the delta od measured can be changed leading to a lowered percentage result.
  • Action
    Diagnostica Stago Inc. sent e-mail notifications on 1/28/2013 to all consignees (laboratory supervisor). The written field safety notice, entitled Important Field Safety Notice, with its response form was attached. The letter identified the affected product and gave a description of the defect. Customers were asked to confirm all the results obtained in the abnormal range by either of the two methods provided. Users are to complete and return the enclosed response form as soon as possible to the Stago Hotline via fax, 973-644-9348. Questions should be directed to the Stago Hotline at 800-725-0607.

Device

Device Recall Diagnostica Stago Inc.
  • Model / Serial
    Lot/Unit Numbers : Combination of All STA-R¿/ STA-R EVOLUTION¿ and lots of STA¿ - LIATEST¿ VWF: AG are involved.    Lot Number Expiry date 108128 2013-03 108512 2013-04 108778 2013-07 109415 2013-10 109591 2014-01
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA and Canada.
  • Product Description
    Vial Label: || 1) LIATEST VWF:Ag Buffer - 5 ml Diagnostica Stago || 2) LIATEST VWF:Ag Latex + 4 ml R3 Diagnostica Stago || 3) LIATEST VWF:Ag Latex Diluent 4 mL Diagnostica Stago || Model, catalogue, number 00518 - 58978 - 58979 || Kit Label: || LIATEST VWF:Ag || DIAGNOSTICA STAGO S.A.S. || 92600 Asni¿res sur Seine (France) || Coagulation Assay
  • Manufacturer
    Diagnostica Stago, Inc.

Manufacturer

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