Events

Recall of Device Recall Hgb Pro Professional Hemoglobin Testing system

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by ITC-Nexus Dx, 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
    57773
  • Event Risk Class
    Class 2
  • Event Number
    Z-1854-2011
  • Event Initiated Date
    2011-01-21
  • Event Date Posted
    2011-03-31
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-11-02
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=97375
  • 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
    System, hemoglobin, automated - Product Code GKR
  • Reason
    Itc has determined that results obtained using certain lots of hgb pro professional hemoglobin test strips may differ from results obtained using a reference hemoglobin testing system.
  • Action
    ITC-Nexus Dx, Inc. sent an Urgent Medical Device Recall letter with return response forms to end users and distributors dated January 21, 2011 via UPS overnight. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to check their inventory to determine if they had an of the affected lots. If they have full boxes or loose containers of the affected lots customers were instructed to stop using the product and remove it from inventory. Customers were requested to fill out the return response form and send it back to ITC via fax, email or mail. For questions customers were instructed to call ITC Technical Support at 800-631-5945 (US) or 732-548-5700 (International)), Extension 4707 or e-mail techsupport@itcmed.com.

Device

Device Recall Hgb Pro Professional Hemoglobin Testing system
  • Model / Serial
    F9HGS005A Exp Date 6/30/2011 F9HGS005B Exp Date 6/30/2011 F9HGS005E Exp Date 6/30/2011 F9HGS005G Exp Date 6/30/2011 F9HGS005H Exp Date 6/30/2011 F9HGS005I Exp Date 6/30/2011 G9HGS006C Exp Date 7/31/2011 G9HGS006D Exp Date 7/31/2011 G9HGS006E Exp Date 7/31/2011 G9HGS006F Exp Date 7/31/2011 G9HGS006H Exp Date 7/31/2011  addtnl lots added as per documentation from ITC dated 3/18/2011  C9HGS002A 3/31/3011 C9HGS002B 3/31/2011 C9HGS002C 3/31/2011 C9HGS002D 3/31/2011 C9HGS002E 3/31/2011 C9HGS002F 3/31/2011 C9HGS002G 3/31/2011 C9HGS002H 3/31/2011 C9HGS003A 4/30/2011 C9HGS003B 4/30/2011 C9HGS003C 4/30/2011 C9HGS003D 4/30/2011 C9HGS003E 4/30/2011 C9HGS003F 4/30/2011 C9HGS003G 4/30/2011 C9HGS003H 4/30/2011 D9HGS004A 4/30/2011 D9GHS004B 4/30/2011 D9HGS004C 5/31/2011 D9HGS004D 5/31/2011 D9HGS004E 5/31/2011 D9HGS004F 5/31/2011 D9HGS004G 5/31/2011 H9HGS007A 8/31/2011 H9HGS007B 8/31/25011 H9HGS007C 8/31/2011 H9HGS007D 8/31/2011 H9HGS007F 8/31/2011 H9HGS007G 8/31/2011 H9HGS007H 8/31/2011 J9HGS008C 10/31/2011 J0HGS008E 10/31/2011 J9HGS008F 10/31/2011 J9HGS008G 10/31/2011 J9HGS008H 10/31/2011 L9HGS009A 11/30/2011 L9HGS009B 11/30/2011 L9HGS009C 11/30/2011 L9HGSS009E 11/30/2011 L9HGS009F 11/30/2011 L9HGS009H 11/30/2011 M9HGS010B 1/31/2012 M9HGS010C 1/31/2012 M9HGS010D 1/31/2012 M9HGS010E 1/31/2012 M9HGS010F 1/31/2012 M9HGS010G 1/31/2012 M9HGS010H 1/31/2012 B0HGS001B 2/29/2012 B0HGS001E 2/29/2012 B0HGS001F 2/29/2012 B0HGS001G 2/29/2012 B0HGS001H 2/29/2012 D0HGS003A 4/30/2012 D0HGS003B 4/30/2012 D0HGS003C 4/30/2012 D0HGS003E 4/30/2012 D0HGS003F 4/30/2012 D0HGS003G 4/30/2012 D0HGS003H 4/30/2012 E0HGS004A 5/31/2012 E0HGS004B 5/31/2012 E0HGS004C 5/31/2012 E0HGS004D 5/31/2012 E0HGS004F 5/31/2012 E0HGS004G 5/31/2012 E0HGS004H 5/31/2012 E0HGS004J 5/31/2012 E0HGS006A 5/31/2012 E0HGS006B 5/31/2012 E0HGS006C 5/31/2012 E0HGS006D 5/31/2012 E0HGS006E 6/30/2012 E0HGS006G 6/30/2012 E0HGS006H 6/30/2012 F0HGS008A 6/30/2012 F0HGS008B 6/30/2012 F0HGS008C 6/30/2012 F0HGS008D 6/30/2012 F0HGS008G 6/30/2012 F0HGS008H 6/30/2012 F0HGS08HJ 6/30/2012 G0HGS009C 7/31/2012 G0HGS009E 7/31/2012 G0HGS009F 7/31/2012 G0HGS009G 7/31/2012 G0HGS009H 7/31/2012 H0HGS010A 8/31/2012 H0HGS010B 8/31/2012 H0HGS010C 8/31/2012 H0HGS010E 8/31/2012 H0HGS010F 8/31/2012 H0HGS010G 8/31/2012 J0HGS011A 9/30/2012 J0HGS011C 9/30/2012 J0HGS011D 9/30/2012 J0HGS011E 9/30/2012 J0HGS011F 9/30/2012 J0HGS011H 9/30/2012
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and the countries of India, Oman, South Africa, and Singapore
  • Product Description
    HGBPROKIT which contains one meter and one container of 25 test strips. HGB TEST 100; HGB PRO TEST STRIPS -100, includes four containers of 25 test strips per container; International Technidyne Corporation || The Hgb Pro Professional Hemoglobin Testing System Consists of a portable battery operated meter and single-use test strips for the quantitative measurement of total hemoglobin from capillary and venous whole blood. The Hgb Pro Professional Hemoglobin Testing System is designed for near patient testing in a professional facility and is not intended for home use.
  • Manufacturer
    ITC-Nexus Dx, Inc.

Manufacturer

ITC-Nexus Dx, Inc.
  • Manufacturer Address
    ITC-Nexus Dx, Inc., 6-8 Olsen Ave, Edison NJ 08820-2419
  • Manufacturer Parent Company (2017)
    Samsung Electronics Co., Ltd.
  • Source
    USFDA