Sysmex America, Inc. recalls Sysmex PS-10 Sample Preparation System with software version 1.5 and 1.6., Catalog Number BQ716341. Product usage for a…

Recall date

January 6, 2025

Source

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

Recall number

Z-1113-2025

FDA classification

Class II

Brand / firm

Sysmex America, Inc.

Sold / distributed

US Nationwide.

Why it was recalled

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.

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 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.