Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Sysmex PS-10 Sample Preparation System Catalog number:BQ716341 - Product Usage: Recalled by Sysmex America, Inc. Due to Insufficient amount of antibody without an error message...

Date: July 6, 2020
Company: Sysmex America, Inc.
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Sysmex America, Inc. directly.

Affected Products

Sysmex PS-10 Sample Preparation System Catalog number:BQ716341 - Product Usage: is a fully automated, user configurable, open system intended for use to prepare human specimens for subsequent analysis on flow cytometers.

Quantity: 8 units

Why Was This Recalled?

Insufficient amount of antibody without an error message or alarm

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Sysmex America, Inc.

Sysmex America, Inc. has 11 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report