FDA-Device2019-08-07Class II
Stratus CS Acute Care cTNI TestPak, SMN 10445071 Product Usage: In vitro diagnostic test for the measurement of cardiac troponin I in heparinized plasma. Cardiac troponin I measurements can be used as an aid in the diagnosis of acute myocardial infarction (AMI).
Siemens Healthcare Diagnostics Inc
Hazard
Potential for increased rate of false positive results and/or increased rate of random non-repeatable false positive results.
Sold states
US Nationwide Distribution
Affected count
2312
Manufactured in
2 Edgewater Dr, N/A, Norwood, MA, United States
Products
Stratus CS Acute Care cTNI TestPak, SMN 10445071 Product Usage: In vitro diagnostic test for the measurement of cardiac troponin I in heparinized plasma. Cardiac troponin I measurements can be used as an aid in the diagnosis of acute myocardial infarction (AMI).
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2135-2019Don't want to check this manually?
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