Medical Device Recall: Stratus CS Acute Care cTNI TestPak.IVD test for cardiac troponin I in heparinized plasma.
Siemens Healthcare Diagnostics Inc · March 31, 2025
Reason for Recall
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.
Distribution
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.
States Affected
NATIONWIDE
Quantity Affected
367 units
Source: FDA (openFDA Device Enforcement)
Recall number: Z-1673-2025
Status: ongoing
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