# FDA recall Z-0727-2025

> **Beckman Coulter, Inc.** · Class II · device recall initiated 2024-11-18.

## Product

Access hsTnI Reagent, REF B52699, Immunoassay Method, Troponin Subunit.  For the quantitative determination of cardiac troponin I (cTnI) levels in human serum and plasma.

## Reason for recall

Beckman Coulter, Inc. is recalling their Access hsTnI assay, a medical device by correction. The reason for the recall is: high troponin antigen (>55,000 pg/mL) can contaminate an analyzers probe and cause inter-assay carryover due to insufficient washing. The contamination can cause a falsely elevated Access hsTnI result in subsequent sample(s) which can impact patient care (potentially but not limited to unnecessary coronary imaging or diagnostic catheterization) if the result is near the medical decision points.

## Distribution

Worldwide

## Key facts

- **Recall number:** Z-0727-2025
- **Recalling firm:** Beckman Coulter, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-11-18
- **Report date:** 2025-01-01

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Chaska, MN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0727-2025

## Citation

> AI Analytics. FDA recall Z-0727-2025. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-0727-2025. Source: US FDA. Licensed CC0.

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