Home / Recalls / International Technidyne Corp. / Z-0837-2013

Z-0837-2013 Class II Terminated

Recalled by International Technidyne Corp. — Edison, NJ

Recall Details

Product Type
Devices
Report Date
February 27, 2013
Initiation Date
September 28, 2012
Termination Date
January 9, 2014
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
11,742 boxes US (25 cuvettes per box); 22,968 boxes OUS (25 cuvettes per box)

Product Description

Pro Time Microcoagulation System/ Pro Time 3 Cuvette, Pro3-4, Pro3-25, and Pro3-50. International Technidyne Corporation. The Pro Time Microcoagulation System is a portable battery operated instrument with a disposable cuvette for quantitative determination of prothrombin time from fingerstick whole blood or anticoagulant free venous whole blood.

Reason for Recall

Some Pro Time3 Test Cuvettes within a specified lot range may recover lower than expected Prothrombin Time/International Normalized Ratio (PT/INR) results.

Distribution Pattern

Worldwide Distribution - USA (nationwide) and Internationally to Bermuda, Canada, Chile, Denmark, Germany, Italy, Latvia, Lithuania, Malaysia, Philippines, South Africa, Spain, Switzerland, Taiwan, and United Arab Emirates.

Code Information

Pro3-25 A2K3C001 1/31/2013 A2K3C002 1/31/2013 A2P3C003 1/31/2013 A2P3C004 1/31/2013 A2K3C005 1/31/2013 A2K3C006 1/31/2013 A2K3C007 1/31/2013 A2K3C008 1/31/2013 A2K3C009 1/31/2013 A2K3C011 1/31/2013 A2K3C013 1/31/2013 A2K3C015 1/31/2013 A2K3C016 1/31/2013 A2K3C017 1/31/2013 A2K3C018 1/31/2013 A2K3C019 1/31/2013 A2K3C020 1/31/2013 A2K3C021 1/31/2013 A2K3C022 1/31/2013 A2K3C023 1/31/2013 A2K3C0241/31/2013 A2K3C025 1/31/2013 A2K3C026 1/31/2013 A2K3C027 1/31/2013 B2K3C028 2/28/2013 B2K3C030 2/28/2013 B2K3C031 2/28/2013 B2K3C032 2/28/2013 B2K3C033 2/28/2013 B2K3C034 2/28/2013 B2K3C035 2/28/2013 B2K3C036 2/28/2013 B2K3C037 2/28/2013 B2K3C038 2/28/2013 B2K3C039 2/28/2013 B2K3C040 2/28/2013 B2K3C041 2/28/2013 B2K3C042 2/28/2013 B2K3C043 2/28/2013 B2K3C044 2/28/2013 B2K3C045 2/28/2013 B2K3C046 2/28/2013 C2K3C048 3/31/2013 C2K3C049 3/31/2013 C2K3C050 3/31/2013 C2K3C051 3/31/2013 C2K3C052 3/31/2013 C2K3C053 3/31/2013 C2K3C054 3/31/2013 C2K3C055 3/31/2013 C2K3C056 3/31/2013 C2K3C058 3/31/2013 C2K3C059 3/31/2013 C2K3C061 3/31/2013 D2K3C078 4/30/2013 M1K3C474 12/31/2012 M1K3C475 12/31/2012 M1K3C476 12/31/2012 M1K3C477 12/31/2012 M1P3C478 12/31/2012 M1P3C479 12/31/2012 M1P3C480 12/31/2012 M1P3C481 12/31/2012 M1P3C482 12/31/2012 PRO3-4 A2K3H015 1/31/2013 B2K3H029 2/28/2013 B2K3H033 2/28/2013 B2K3H047 2/28/2013 C2K3H049 3/31/2013 C2K3H055 3/31/2013 C2K3H057 3/31/2013 PRO3-50 B2P3C029 2/28/2013 B2P3C030 2/28/2013 B2P3C033 2/28/2013 C2P3C057 3/31/2013