# FDA recall Z-1901-2025

> **Beckman Coulter, Inc.** · Class II · device recall initiated 2025-05-05.

## Product

Access Testosterone assay, Catalog Number 33560

## Reason for recall

Inadequate preventative maintenance (PM)  performed on the scales of the RPL5 fill line, led to splashing (cross-contamination) between the wells of testosterone reagent packs lot 538081, which could potentially result in up to a 34% increase or a 23% decrease in patient results.

## Distribution

US State: FL. UAE, Vietnam

## Key facts

- **Recall number:** Z-1901-2025
- **Recalling firm:** Beckman Coulter, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-05-05
- **Report date:** 2025-06-11

- **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-1901-2025

## Citation

> AI Analytics. FDA recall Z-1901-2025. Retrieved 2026-07-12 from https://api.ai-analytics.org/recall/Z-1901-2025. Source: US FDA. Licensed CC0.

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*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*