Events

Recall of Device Recall Hemochron Signature Elite Whole Blood Microcoagulation System

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
    54768
  • Event Risk Class
    Class 2
  • Event Number
    Z-0893-2011
  • Event Initiated Date
    2010-03-31
  • Event Date Posted
    2011-03-01
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-09-25
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=89130
  • 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
    Upc Reader (bar code reader) - Product Code RFZ
  • Reason
    There is a mismatch between the class of the laser barcode scanner and the labeling of the hemochron signature elite: some of the devices were inadvertently equipped with class ii laser barcode scanner instead of the intended class i barcode scanner.
  • Action
    Urgent - Medical Device Recall - Hemochron Signature Elite letters, dated February 24, 2010, by Federal Express to all direct customers. The letter informed customers of the issue and stated that the problem does not negatively affect the performance of the product and to continue using the product as intended. In addition, customers are to notify the appropriate personnel about the notice, complete and return the attached form, and an ITC representative will contact customers to discuss arrangements to re-label their devices. Customers can contact ITC Technical Support at 800-579-2255 (US) or 732-548-5700 ext 4700 (International) if they have any questions regarding this issue and notice. Customers can also email sigelitescan@itcmed.com with questions.

Device

Device Recall Hemochron Signature Elite Whole Blood Microcoagulation System
  • Model / Serial
    Serial numbers SE2830 to SE2854 (inclusive); SE2880 to SE4789 (inclusive); SE0260, SE0366, SE0567, SE0764, SE0843, SE0970, SE1086, SE1198, SE1208, SE1212, SE1438, SE1456, SE1580, SE1711, SE2029, SE2136, SE2602, and SE2618.
  • Device Class
    Not Classified
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- United Arab Emirates, Belgium, Canada, Switzerland, Germany, Denmark, France, United Kingdom, Ireland, Iceland, Italy, Kuwait, Liechtenstein, Netherlands, Oman, Qatar, Saudi Arabia, Sweden, and Singapore.
  • Product Description
    Hemochron Signature Elite Whole Blood Microcoagulation (IVD) System. || The system is intended to be used only with test cuvettes that are available from ITC.
  • 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