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U.S. Department of Health and Human Services

Enforcement Report - Week of February 27, 2013

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Event Detail

Event ID 64076
Product Type Devices
Status Ongoing
Recalling Firm International Technidyne Corp.
City Edison
State NJ
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-09-28
Initial Firm Notification of
Consignee or Public
Letter
Distribution Pattern Worldwide Distribution - USA (nationwide) and Internationally to Bermuda, Canada, Chile, Denmark, Germany,Italy,Latvia, Lithuania, Malaysia, Phillipines, South Africa, Spain, Switzerland, Taiwan, and United Arab Emirates.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Pro Time Microcoagulation System/ Pro Time 3 Cuvette International Technidyne Corporation 23 Nevsky Street Edison, NJ 08820 The Pro Time Microcoagulation System is a portable batter operated instrument with a disposable cuvette for quantitative determination of prothrombin time from fingerstick whole blood or anticoagulant free venous whole blood. 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 2K3C024 1/31/2013 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 B2K3CO39 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 3/31/2012 C2K3C059 3/31/2013 C2K3C061 3/31/2013 D2K3C078 4/30/2013 M1K3C474 12/31/2012 M1K3C475 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 B2O3C033 2/28/2013 C2P3C057 3/31/2013 Class II Some Pro Time3 Test Cuvettes within a specified lot range may recover lower than expected Prothrombin Time/International Normalized Ratio (PT/INR) results. 11742 boxes US (25 cuvettes per box); 22,968 boxes OUS (25 cuvettes per box) Z-0837-2013
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