03ba9f5b_port___Week_of_August_15__2012__Classification
[Product Type] Devices [Product Description] i-Stat BNP cartridges Abbott Point of Care Inc. Abbott Park, IL 60064 USA The i-Stat BNP test is an in vitro diagnostic test for the quantitative measurement of B-type Natriuertic Peptide (BNP) in whole blood or plasma samples using EDTA as the anticoagulant. BNP measurements can be used as an aid in the diagnosis and assessment of the severity of congestive heart failure. [Code Info] List number 06F30-01, 06F30-02, 03P93-25, 600-9010-25 All lots [Reason for Recall] Abbott Point of Care has determined that the frequency of suppressed results for i-Stat cTnl, BNP and CK-MP cartridges is affected by atmospheric pressure. [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