Siemens Healthcare Diagnostics Inc recalls Stratus CS Acute Care cTNI TestPak, SMN 10445071 Product
Recalled Product
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).
Hazard / Issue
Potential for increased rate of false positive results and/or increased rate of random non-repeatable false positive results.
Issued by
FDA
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