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FDAMarch 31, 2025device

Stratus CS Acute Care cTNI TestPak.IVD test for cardiac troponin I in heparinized plasma.

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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.

What to do

FDA enforcement status: Ongoing

Brands named

siemens healthcare diagnosticssiemenssiemens healthcare

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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