Siemens Healthcare Diagnostics Inc recalls Stratus CS Acute Care cTNI TestPak, SMN 10445071 Product Usage: In vitro diagnostic test for the measurement of cardiac…

Recall date

May 29, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2135-2019

FDA classification

Class II

Brand / firm

Siemens Healthcare Diagnostics Inc

Sold / distributed

US Nationwide Distribution

Why it was recalled

Potential for increased rate of false positive results and/or increased rate of random non-repeatable false positive results.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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).