Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Stratus CS Acute Care cTNI TestPak.IVD test for cardiac troponin Recalled by Siemens Healthcare Diagnostics Inc Due to Siemens Healthcare Diagnostics Inc., is recalling their Stratus...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Siemens Healthcare Diagnostics Inc directly.
Affected Products
Stratus CS Acute Care cTNI TestPak.IVD test for cardiac troponin I in heparinized plasma.
Quantity: 367 units
Why Was This 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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Siemens Healthcare Diagnostics Inc
Siemens Healthcare Diagnostics Inc has 75 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report