# FDA recall Z-2135-2019

> **Siemens Healthcare Diagnostics Inc** · Class II · device recall initiated 2019-05-29.

## Product

Stratus CS Acute Care cTNI TestPak, SMN 10445071    Product Usage:  In vitro diagnostic test for the measurement of cardiac troponin I in heparinized plasma. Cardiac troponin I measurements can be used as an aid in the diagnosis of acute myocardial infarction (AMI).

## Reason for recall

Potential for increased rate of false positive results and/or increased rate of random non-repeatable false positive results.

## Distribution

US Nationwide Distribution

## Key facts

- **Recall number:** Z-2135-2019
- **Recalling firm:** Siemens Healthcare Diagnostics Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-05-29
- **Report date:** 2019-08-07
- **Termination date:** 2022-05-12

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Norwood, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2135-2019

## Citation

> AI Analytics. FDA recall Z-2135-2019. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-2135-2019. Source: US FDA. Licensed CC0.

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