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 Recalled by Siemens Healthcare Diagnostics Inc Due to Potential for increased rate of false positive results...
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, 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).
Quantity: 2312
Why Was This Recalled?
Potential for increased rate of false positive results and/or increased rate of random non-repeatable false positive results.
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