# FDA recall Z-2927-2020

> **Siemens Healthcare Diagnostics, Inc.** · Class II · device recall initiated 2020-07-24.

## Product

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

## Reason for recall

Dimension Vista High Sensitivity Troponin I (TNIH) may exhibit a negative bias with patient samples

## Distribution

Nationwide

## Key facts

- **Recall number:** Z-2927-2020
- **Recalling firm:** Siemens Healthcare Diagnostics, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-07-24
- **Report date:** 2020-09-09
- **Termination date:** 2023-06-07

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Newark, DE, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2927-2020

## Citation

> AI Analytics. FDA recall Z-2927-2020. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-2927-2020. Source: US FDA. Licensed CC0.

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