Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Dimension Vista High Sensitivity Troponin I (TNIH) Flex reagent cartridge-IVD-In Recalled by Siemens Healthcare Diagnostics, Inc. Due to Dimension Vista High Sensitivity Troponin I (TNIH) may...
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
Dimension Vista High Sensitivity Troponin I (TNIH) Flex reagent cartridge-IVD-In vitro diagnostic use in the quantitative measurement of cardiac troponin I in human plasma Catalog Number K6427, SMN# 104471067
Quantity: US: 1239 units OUS: 3387
Why Was This Recalled?
Dimension Vista High Sensitivity Troponin I (TNIH) may exhibit a negative bias with patient samples
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Siemens Healthcare Diagnostics, Inc.
Siemens Healthcare Diagnostics, Inc. has 452 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report