03ba9f5b_port___Week_of_August_15__2012__Classification
[Product Type] Devices [Product Description] i-Stat cTnl cartridges Abbott Point of Care Inc. Abbott Park, IL 60064 USA The i-Stat cTnl test is an in vitro diagnostic test for the quantitative measurement of cardiac troponin I in heparinized whole blood or plasma samples. Cardiac troponin I measurements can be used as an aid in the diagnosis and treatment of myocardial infarction and in the risk stratification of patients with acute coronary syndromes with respect to their relative risk of mortality. The cartridge is to be used with the i-Stat Analyzer, but not with the i-Stat Portable Clinical Analyzer or the Philips Medical System (formerly Agilent Technologies) Blood Analysis Module (BAM). As part of the i-Stat System, the cTnl test is to be used by trained health care professionals in accordance with a facility's policies and procedures. [Code Info] List number 06F15-03, 06F15-04, 03P90-23, 600-9009-25 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