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 CV-11 Sample Unit Recalled by Sysmex America, Inc. Due to When excessive amounts of urine spills on the...

Date: January 21, 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 CV-11 Sample Unit, an integrated modular sampler that conveys specimens to either the UF-5000 or UD-10 analyzers.

Quantity: 40 units

Why Was This Recalled?

When excessive amounts of urine spills on the rack transport track and reaches the electrical components of the CV-11 conveyor, there is a potential for smoke and/or sparks which may present a combustion hazard.

Where Was This Sold?

This product was distributed to 3 states: FL, IL, VT

Affected (3 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