Device Recall Hgb Pro Professional Hemoglobin Testing system

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

Hematology and Pathology Devices

2

No

Worldwide Distribution - USA (nationwide) and the countries of India, Oman, South Africa, and Singapore

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.