Hisashi Ietsugu

Sysmex America filed an action against the United States and several federal officials before the US Court of International Trade on 22 January 2026. The case was stayed shortly after filing and reassigned in July 2026.

Attribution

US subsidiary as claimant; no allegation of wrongdoing against Ietsugu

Japan's competition authority considered that, from at least August 2019 until 2024, Sysmex had implemented a policy requiring purchasers of certain coagulation analysers to buy and use specified Sysmex D-dimer/FDP reagents even though competing reagents could technically be used. Following an investigation opened in 2024, the JFTC approved a commitment plan in February 2025 covering cessation of practices, training, audits, reporting mechanisms and monitoring for five years.

State of the evidence

Official JFTC suspicion of an Antimonopoly Act violation followed by approved commitment plan

Legal status — source text

Commitment decision; JFTC expressly states that approval is not a formal finding of infringement

Attribution

Group-level competition policy during Ietsugu's senior executive tenure; no personal finding

In 2017, Beckman Coulter brought proceedings in the Düsseldorf Regional Court against Sysmex entities for alleged patent infringement. A first-instance ruling found infringement in 2019; Sysmex appealed and simultaneously brought proceedings challenging the patent's validity.

State of the evidence

Documented multi-year patent litigation in Germany and related jurisdictions

Legal status — source text

Civil intellectual property litigation; Sysmex disputed infringement and patent validity

Attribution

Company litigation under Ietsugu's executive governance

In 2020, companies linked to Uniface/Rocket sued Sysmex in Brussels for alleged breaches of a software licence agreement and copyright, seeking approximately €324 million. Sysmex disputed the claims. In August 2021, the first-instance court dismissed all claims; the claimants appealed before a settlement ended the case in January 2022.

State of the evidence

Lawsuit, first-instance victory for Sysmex, appeal and settlement documented

Attribution

Company dispute under Ietsugu's executive governance

Sysmex announced a voluntary Japanese recall of several batches of coagulation reagents after discovering a defect in manufacturing equipment that could cause bottle caps to seal inadequately. Evaporation or increased product concentration could affect measurement data.

Legal status — source text

Voluntary Class II-equivalent recall notice; no personal sanction

Sysmex recalled several Fluorocell PLT batches in 2017 and again in 2018 because a non-compliant component could produce falsely low PLT-F and IPF results. European field safety notices warned that incorrect interpretation could lead to inappropriate diagnostic or treatment decisions.

State of the evidence

Two documented FDA recalls and a European field safety notice

Legal status — source text

FDA recalls/field safety corrective action; no personal charges

The FDA documented a recall of Sysmex XN-10 and XN-20 analysers after identification of a defect capable, under certain conditions, of producing artificially elevated haemoglobin and platelet count values. More than a thousand units distributed in the United States were affected, and the recall was international in scope.

State of the evidence

Documented FDA Class II recall

Legal status — source text

FDA Class II recall; no personal charges

Sysmex conducted two US recalls of its Stromatolyser-IM reagent, in 2009 and 2011, after Pseudomonas contamination was detected. The defect could generate false platelet fragment or aggregate signals and affect interpretation of certain haematology results.

State of the evidence

Two documented FDA Class II recalls involving the same reagent family and contamination hazard

Legal status — source text

FDA Class II recalls; no personal charges against Ietsugu

Japan's Health Ministry published two Class II recalls involving Sysmex analysers in the early 2000s: one concerned software that could associate incorrect information received from the host system; the other concerned a rare situation in which a sample number and its result could be shifted by one position.

State of the evidence

Two official Japanese Class II recall notices