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U.S. Department of Health and Human Services

Enforcement Report - Week of August 15, 2012

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Product Detail

Product Description 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.
Recall Number Z-2157-2012
Classification Class II
Code Info List number 04J50-01 04J5O-02 03P89-24 Lots begininng with R11 or R12
Product Distributed Qty 2,950,296 cartridges US; 156,408 cartridges OUS
Reason For Recall The i-STAT PT/INR cartridges have the potential to exhibit incorrectly elevated results.

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