Siemens Healthcare Diagnostics Inc recalls Stratus CS Acute Care cTNI TestPak.IVD test for cardiac troponin I in heparinized plasma.

Recall date

March 31, 2025

Source

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

Recall number

Z-1673-2025

FDA classification

Class II

Brand / firm

Siemens Healthcare Diagnostics Inc

Sold / distributed

Worldwide - US Nationwide distribution in the states of CA, IL, KS, MI, MO, NJ, NY, OH, OK, PA, SC & WI. The countries of Austria, Canada, Chile, France, Germany, Iraq, Italy, Malaysia, North Macedonia, Saudi Arabia, Serbia, Slovenia, Spain, Sweden, Switzerland & Vietnam.

Why it was recalled

Siemens Healthcare Diagnostics Inc., is recalling their Stratus CS Acute Care cTNI TestPak, an IVD test for cardiac troponin I in heparinized plasma by removal. The reason for the recall is an increased occurrence of random non-repeatable false positive cardiac Troponin l(cTnI) results at any point during the TestPaks shelf life when using the Stratus CS cTnI Acute Care Testpak.

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.IVD test for cardiac troponin I in heparinized plasma.