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U.S. Department of Health and Human Services

Enforcement Report - Week of August 15, 2012

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Event Detail

Event ID 62536
Product Type Devices
Status Ongoing
Recalling Firm Abbott Point Of Care Inc.
City Princeton
State NJ
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-03-01
Initial Firm Notification of
Consignee or Public
Letter
Distribution Pattern Worldwide Distribution -- (USA) nationwide

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
I-STAT PT/INR cartridge Abbott Point of Care Inc. Abbott Park, IL 60064 USA This cartridge is useful for monitoring patients receiving oral anticoagulation therapy such as Coumadin or warfarin. List number 04J50-01 04J5O-02 03P89-24 Lots begininng with R11 or R12 Class II The i-STAT PT/INR cartridges have the potential to exhibit incorrectly elevated results. 2,950,296 cartridges US; 156,408 cartridges OUS Z-2157-2012
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