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U.S. Department of Health and Human Services

Enforcement Report - Week of January 30, 2013

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Product Detail

Product Description 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.
Recall Number Z-0716-2013
Classification Class II
Code Info List number 06F15-03, O6F15-04, 03P90-25, 600-9009-25 Lot number P12179
Product Distributed Qty 560 boxes (25 cartridges in each box)
Reason For Recall APOC has determined that 10 boxes of i-Stat cTnI cartridges from lot P12179 have an incorrect barcode applied to the cartridge portion pack.

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 Telephone
Distribution Pattern Worldwide Distribution.