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Abbott Point of Care Canada Limited recalls Abbott Point of Care i-Stat cTnI cartridge. The i-Stat cardiac troponin I (cTnI) test is an in vitro diagnostic test
Recalled January 30, 2013 · FDA recall Z-0716-2013 · Abbott Point of Care Canada
Hazard
APOC has determined that 10 boxes of i-Stat cTnI cartridges from lot P12179 have an incorrect barcode applied to the cartridge portion pack. · FDA Class II
Units
560 boxes (25 cartridges in each box)
Sold at
Worldwide Distribution.
Description
APOC has determined that 10 boxes of i-Stat cTnI cartridges from lot P12179 have an incorrect barcode applied to the cartridge portion pack.
Product
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.
Manufacturer(s)
Abbott Point of Care Canada Limited
Made in
Canada
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →