03ba9f5b_port___Week_of_August_15__2012__Classification
[Product Type] Devices [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. [Code Info] List number 04J50-01 04J5O-02 03P89-24 Lots begininng with R11 or R12 [Reason for Recall] The i-STAT PT/INR cartridges have the potential to exhibit incorrectly elevated results. [Recalling Firm] Abbott Point Of Care Inc. [Classification] 
Class II
C l a s s I I
C l a s s I I I
C l a s s I
Enforcement Report - Week of August 15, 2012