# FDA recall Z-0052-2021

> **Siemens Healthcare Diagnostics, Inc.** · Class II · device recall initiated 2020-08-19.

## Product

Dimension LOCI 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: RF627, SMN# 10471068

## Reason for recall

Positive bias across the Analytical Measurement Range of the TNIH assay compared to an unaffected control lot. The average bias observed for  patient samples using lots EB0255 and EA0178 of the Dimension EXL Troponin compared with a control lot was +25%. A maximum bias of +34% in patient samples around the 99th percentile observed

## Distribution

US Nationwide distribution.

## Key facts

- **Recall number:** Z-0052-2021
- **Recalling firm:** Siemens Healthcare Diagnostics, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-08-19
- **Report date:** 2020-10-14
- **Termination date:** 2023-08-25

- **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-0052-2021

## Citation

> AI Analytics. FDA recall Z-0052-2021. Retrieved 2026-07-20 from https://api.ai-analytics.org/recall/Z-0052-2021. Source: US FDA. Licensed CC0.

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