# FDA recall Z-1386-2025

> **Beckman Coulter, Inc.** · Class II · device recall initiated 2025-02-05.

## Product

Access 2 Immunoassay Analyzer, Catalog Number 81600N

## Reason for recall

Beckman Coulter identified that an issue for Access 2 Sample Motors (B48016) due to improper alignment, causing the motors to rub against the sample wheelbase plate and index sensor. The issue was traced to a worn tool used in production (at the supplier), affecting Access 2 sample motors. This could lead to a potential delay in reporting patient test results.

## Distribution

Worldwide - US Nationwide distribution.

## Key facts

- **Recall number:** Z-1386-2025
- **Recalling firm:** Beckman Coulter, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-02-05
- **Report date:** 2025-03-26

- **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-1386-2025

## Citation

> AI Analytics. FDA recall Z-1386-2025. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1386-2025. Source: US FDA. Licensed CC0.

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