Events

Recall of Device Recall HEMOCHRON(R) HEPARIN RESPONSE TEST

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

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
    56114
  • Event Risk Class
    Class 2
  • Event Number
    Z-2110-2010
  • Event Initiated Date
    2010-06-24
  • Event Date Posted
    2010-07-28
  • 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=92693
  • 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
    assay, heparin - Product Code KFF
  • Reason
    An ingredient in the rqchrt whole blood controls for use with hemochron kaolin and celite hrt test tubes may become less potent over time and result in excessive high lqc failures.
  • Action
    ITC sent "URGENT MEDICAL DEVICE RECALL" letters dated June 24, 2010, via Federal Express to Laboratory Director, Clinical Laboratory Manager, or Point of Care Coordinator consignees/customers. The letter described the product, problem and action to be taken by customers. The customers were instructed to check their inventory for the product, if they have boxes or loose vials to please stop using the product, remove it from inventory and contact ITC Technical Support to arrange return. They were also instructed to complete the attached Customer Account Tracking Form, whether or not they have remaining inventory, and return it by fax, email or mail. If you have any questions, please call ITC Technical Support at 800-631-5945 (US) or 732-548-5700 (international), Extension 4707 or email techsupport@itcmed.com.

Device

Device Recall HEMOCHRON(R) HEPARIN RESPONSE TEST
  • Model / Serial
    Test kit lot numbers: H9KHR002, Exp 05/2010 and BOKHR001, Exp 08/2010; RAF 10-016
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA including states of CA, NC, TX, FL, MD, OK, NY, and NJ and country of Italy.
  • Product Description
    RQCHRT HRT Control Level 1 & 2; || Whole Blood controls for use with Hemochron Kaolin and Celite HRT Test Tubes. || 20 vials Whole Blood - 2.0mL; dried || 20 vials Diluent - 4.0 mL || The Hemochron HRT Whole Blood Quality Controls are intended to be used to perform quality control assays using the Hemochron HRT test tubes.
  • Manufacturer
    International Technidyne Corp.

Manufacturer

International Technidyne Corp.
  • Manufacturer Address
    International Technidyne Corp., 6-8 Olsen Avenue, Edison NJ 08820-2419
  • Manufacturer Parent Company (2017)
    Werfenlife Sa.
  • Source
    USFDA