Events

Recall of Device Recall Hemochron Whole Blood Coagulation Systems Activated Clotting Time (ACT)

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
    57405
  • Event Risk Class
    Class 2
  • Event Number
    Z-1093-2011
  • Event Initiated Date
    2010-11-30
  • Event Date Posted
    2011-02-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-08-22
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=96055
  • 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
    Coagulation Instrument - Product Code KQG
  • Reason
    Some activated clotting time (act) tubes may contain a component that does not meet its specification, making it possible for a failure to detect a tube or the presence of a clot.
  • Action
    ITC notified their distributors and end user customers with an Urgent Medical Device Recall letter dated November 29, 2010 through UPS overnight mail. The letter identified the affected product and explained the reason for the recall. Distributors and customers should check their inventory for any affected product. Distributors should immediately discontinue shipment of the affected product and place the product on hold. Then regardless of whether they have any remaining inventory, they should complete the enclosed Distributor Account Tracking Form. The firm will contact them to arrange for any affected product to be returned and will credit them for any unused, returned product. Customers are to stop using the affected product and remove it from their inventory. They should also complete the attached Customer Account Tracking Form and return it to the firm. The firm will contact them to arrange for the return of any affected inventory and will credit the customers for any unused, returned product. If customers believe that they have experienced a problem with the product, they should take any additional actions regarding their records or patients. Questions should be directed to ITC Nexus Dx Technical Support at 800-631-5945 (US) or 732-548-5700 (International) or e-mail techsupport@itcmed.com.

Device

Device Recall Hemochron Whole Blood Coagulation Systems Activated Clotting Time (ACT)
  • Model / Serial
    Lot Number G0FTE157A, Expiration Date 7/31/2013 Lot Number G0FTE158A, Expiration Date 7/31/2013 Lot Number G0FTE159A, Expiration Date 7/31/2013 Lot Number G0FTE159B, Expiration Date 7/31/2013
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution
  • Product Description
    Hemochron Whole Blood Coagulation Systems Activated Clotting Time (ACT); Package label states -International Technidyne Corporation Response Celite ACT Tube HRFTCA510; Lot number and expiration date are listed. Each box contains 95 ACT tubes tests. || Used for heparin anticoagulation monitoring during cardiopulmonary bypass surgery, percutaneous transluminal coronary angioplasty (PTCA), interventional radiology, extracorporeal membrane oxygenation (ECMO), hemofiltration, hemodialysis and critical care.
  • 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