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U.S. Department of Health and Human Services

Enforcement Report - Week of January 30, 2013

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Event Detail

Event ID 64043
Product Type Devices
Status Ongoing
Recalling Firm Abbott Point of Care Canada Limited
City Nepean
Country CA
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-11-01
Initial Firm Notification of
Consignee or Public
Distribution Pattern Worldwide Distribution.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Abbott Point of Care i-Stat cTnI cartridge. The i-Stat cardiac troponin I (cTnI) test is an in vitro diagnostic test for the quantitive measurement of cardiac troponin I (cTnI) in whole blood or plasma. Measurements of cardiac troponin I are used in the diagnosis and treatment of myocardial infarction and as an aid in the risk stratification of patients with acute coronary syndromes with respect to the relative risk of mortality. List number 06F15-03, O6F15-04, 03P90-25, 600-9009-25 Lot number P12179 Class II APOC has determined that 10 boxes of i-Stat cTnI cartridges from lot P12179 have an incorrect barcode applied to the cartridge portion pack. 560 boxes (25 cartridges in each box) Z-0716-2013