# FDA recall Z-2152-2025

> **Beckman Coulter Inc.** · Class II · device recall initiated 2025-06-12.

## Product

Estrone RIA, REF: DSL8700.  Estrone RIA is an IVD used for the quantitative measurement of estrone in human serum and plasma.

## Reason for recall

A specific lot of bovine serum albumin (BSA) used for manufacturing of coated tubes (CT) that are included in the Estrone RIA kit lots caused different affinity of manufactured coated tubes to patient samples, causing falsely increased assay results for the impacted Estrone RIA kits.

## Distribution

US: North Carolina  OUS: Argentina, Austria, Belgium, Canada, France, Germany, Greece, Hungary, Italy, Netherlands

## Key facts

- **Recall number:** Z-2152-2025
- **Recalling firm:** Beckman Coulter Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-06-12
- **Report date:** 2025-07-30

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Brea, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2152-2025

## Citation

> AI Analytics. FDA recall Z-2152-2025. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-2152-2025. Source: US FDA. Licensed CC0.

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