Sysmex America, Inc. recalls Sysmex CV-11 Sample Unit, an integrated modular sampler that conveys specimens to either the UF-5000 or UD-10 analyzers.

Recall date

January 21, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1717-2020

FDA classification

Class II

Brand / firm

Sysmex America, Inc.

Sold / distributed

USA: FL, VT, IL.

Why it was 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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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