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Abbott Point Of Care Inc. recalls i-STAT cTnI cartridges Product Usage: The i-STAT cTnl test is an in vitro diagnostic test for the quantitative mea
Recalled August 29, 2012 · FDA recall Z-2237-2012 · Abbott Point Of Care
Hazard
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. · FDA Class II
Units
7,057675 cartridges US; 772,400 cartridges OUS
Sold at
Worldwide Distribution - US Nationwide, International
Description
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.
Product
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.
Manufacturer(s)
Abbott Point Of Care Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →