FDA recall record · openFDA

Sysmex America, Inc.

2 FDA recalls on record (2025) — 2 device. 2 still ongoing.

Class I (most serious)

Class II

Class III

ongoing

How to read this. A recall count is not a quality verdict — large manufacturers recall more simply by volume, and a voluntary recall is the safety system working as intended. The signal to weight is the Class I count (the FDA's most-serious tier — reasonable probability of serious harm or death) and whether recalls are still ongoing. Most recalls are Class II/III. "Ongoing" reflects openFDA's last-published status — device recalls often stay marked ongoing long after they're resolved in practice; confirm current status at the FDA.

Most common reasons

Under specific conditions, the lift's electromagnetic holding force may disengage unexpectedly, allowing unintended down 1

Sysmex was made aware of a report of false results due to carry-over caused by the sporadic omission of the probe wash s 1

Recalls

TS-10/TS-10H Tube Sorter, automatic sorting system for sorting barcoded sample tubes, Catalog Number BN168792, running s Class II 2025-12-15 Sysmex PS-10 Sample Preparation System with software version 1.5 and 1.6., Catalog Number BQ716341. Product usage for a Class II 2025-01-06

RECORDED — these are the FDA's published recall enforcement records (openFDA). Recalls are listed under the exact firm name as filed; a large manufacturer may also file under name variants, so this may not be the company's complete cross-variant record — confirm at the FDA recall database. This page informs and routes; it is not medical advice or a verdict on the company.

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