# FDA recall Z-1340-2022

> **Siemens Healthcare Diagnostics, Inc.** · Class II · device recall initiated 2022-05-18.

## Product

Dimension LTNI -In vitro diagnostic test intended to quantitively measure cardiac troponin-I levels in human serum and heparinized plasma to aid in the diagnosis of myocardial infarction.  Siemens Material Number (SMN)/REF (Catalog Number): 10444896/RF521

## Reason for recall

Positive bias with Lithium Heparin plasma samples from  individuals that are expected to be below the 99th percentile of 0.07 ng/mL [0.07 ¿g/L], may lead to inappropriate intervention for myocardial infarction

## Distribution

Worldwide distribution - US Nationwide distribution in the states of AL, AR, CA, IL MN, MS, NC, ND, NH, OK, SD, TN, TX, WA and the countries of Argentina, Brazil, Canada, France, Germany, India, Mexico, Poland, Portugal, Slovakia, Spain.

## Key facts

- **Recall number:** Z-1340-2022
- **Recalling firm:** Siemens Healthcare Diagnostics, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2022-05-18
- **Report date:** 2022-07-13
- **Termination date:** 2025-02-13

- **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-1340-2022

## Citation

> AI Analytics. FDA recall Z-1340-2022. Retrieved 2026-06-05 from https://api.ai-analytics.org/recall/Z-1340-2022. Source: US FDA. Licensed CC0.

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