Class II — Potential Health Hazard

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...

Date: July 24, 2020
Company: Siemens Healthcare Diagnostics, Inc.
Status: Terminated
Source: FDA (Device)

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.

Affected (51 states)Not affected

About Siemens Healthcare Diagnostics, Inc.

Siemens Healthcare Diagnostics, Inc. has 452 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report