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U.S. Department of Health and Human Services

Class 2 Device Recall Hgb Pro Professional Hemoglobin Testing system

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  Class 2 Device Recall Hgb Pro Professional Hemoglobin Testing system see related information
Date Initiated by Firm January 21, 2011
Date Posted March 31, 2011
Recall Status1 Terminated 3 on November 02, 2012
Recall Number Z-1854-2011
Recall Event ID 57773
Product Classification System, hemoglobin, automated - Product Code GKR
Product 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.
Code Information 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    
Recalling Firm/
Manufacturer		 ITC-Nexus Dx, Inc.
6-8 Olsen Ave
Edison NJ 08820-2419
For Additional Information Contact Mr. Ellie Fox
732-548-5700 Ext. 4476
Manufacturer Reason
for Recall		 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.
FDA Determined
Cause 2		 Other
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.
Quantity in Commerce 2500 containers + 50,563 addtnl containers =53063 containers
Distribution Worldwide Distribution - USA (nationwide) and the countries of India, Oman, South Africa, and Singapore
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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