FDA-Device2013-01-30Class II
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.
Abbott Point of Care Canada Limited
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.
Sold states
Worldwide Distribution.
Affected count
560 boxes (25 cartridges in each box)
Manufactured in
185 Corkstown Road, N/A, Nepean, N/A, Canada
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0716-2013Don't want to check this manually?
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