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U.S. Department of Health and Human Services

Enforcement Report - Week of August 29, 2012

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Event Detail

Event ID 62410
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 2012-03-07
Initial Firm Notification of
Consignee or Public
Letter
Distribution Pattern Worldwide Distribution - US Nationwide, International

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
i-STAT cTnI cartridges Product Usage: 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 I troponin measurement cane 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. 510(K)K031739 List Number 06F15-03, 06F15-04, 03P90-25, 600-9009-25 All lots Class II Abbott Point of Care has determined that i-Stat CTNL cartridges have the potential to exhibit incorrectly elevated cardiac troponin I results. This recall was expanded on July 19 2012 to include additional information regarding user documentation. 7,057675 cartridges US; 772,400 cartridges OUS Z-2237-2012
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