Events

Recall of directCHECK Whole Blood Control

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by International Technidyne Corporation.

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
    55404
  • Event Risk Class
    Class 2
  • Event Number
    Z-1786-2010
  • Event Initiated Date
    2010-04-15
  • Event Date Posted
    2010-06-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-09-23
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=90767
  • 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 control - Product Code GGN
  • Reason
    Indication not cleared or approved. the acceptable performance range published in the directcheck microcoagulation quality control package insert is incorrect.
  • Action
    Notification letters were sent vis Federal Express on April 15, 2010 to all distributors and end users to return unused product or to replace the package insert. Please direct questions ITC Technical Support at phone 800-631-5945 Ext. 4707.

Device

directCHECK Whole Blood Control
  • Model / Serial
    Catalog number.Code number: DCJPT-A; Lot number G9DPA005; Exp. 1/31/2011.
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributors and medical facilities in AZ, CA, IL, KY, MA, MD, ME, MO, PA, WA. Foreign distribution to Australia, Canada, Switzerland, Germany, Spain, Quatar, and Saudi Arabia.
  • Product Description
    directCHECK Whole Blood Control; || for Hemochron J. Microcoagulation Systems.
  • Manufacturer
    International Technidyne Corporation

Manufacturer

International Technidyne Corporation
  • Manufacturer Address
    International Technidyne Corporation, 23 Nevsky St, Edison NJ 08820-2425
  • Manufacturer Parent Company (2017)
    Werfenlife Sa.
  • Source
    USFDA