# FDA recall Z-1113-2025

> **Sysmex America, Inc.** · Class II · device recall initiated 2025-01-06.

## Product

Sysmex PS-10 Sample Preparation System with software version 1.5 and 1.6., Catalog Number BQ716341.  Product usage for automated pipetting, diluting, and specimen processing workstations for flow cytometric analysis.

## Reason for recall

Sysmex was made aware of a report of false results due to carry-over caused by the sporadic omission of the probe wash step during antibody pipetting on the PS-10 Sample Preparation System.

## Distribution

US Nationwide.

## Key facts

- **Recall number:** Z-1113-2025
- **Recalling firm:** Sysmex America, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-01-06
- **Report date:** 2025-02-12

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Lincolnshire, IL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1113-2025

## Citation

> AI Analytics. FDA recall Z-1113-2025. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-1113-2025. Source: US FDA. Licensed CC0.

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