FDA recall record · openFDA

Beckman Coulter Mishima K.K.

6 FDA recalls on record (2024–2026) — 6 device. 6 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

A delay in results may occur. When clinical chemistry analyzer calibration monitor with PC installed with Microsoft SQL 2

There are two software bug issues with the analyzer. Issue 1: When a dedicated rack is reserved for calibration, after a 1

A manufacturing defect in the sample probe (S probe). The corners of the tip of the defective S probe are rounded and ch 1

Due to a software issues, after the instrument processes 250 racks cumulatively, any subsequent racks with samples requi 1

Sample probes with defective probe tips, when used with clinical chemistry analyzers, may lead to a lower concentration 1

Recalls

CHEMISTRY ANALYZER AU5800, REF: B96697, B96698, B23279, B23280, B23281 Class II 2026-01-30 DxC 700 AU, REF: B86444, B86446 Class II 2026-01-30 Sample probe sucks a sample dispensed into a tube or cup and discharges the appropriate amount into a cuvette. Lot Class II 2025-04-30 Sample probe sucks a sample dispensed into a tube or cup and discharges the appropriate amount into a cuvette. Lot Class II 2025-04-30 DxC 500 AU Clinical Chemistry Analyzer, REF C63520 is an automated chemistry analyzer that measures analytes in sampl Class II 2024-06-05 DxC 500 AU Clinical Chemistry Analyzer, REF C63520 is an automated chemistry analyzer that measures analytes in sampl Class II 2024-07-10

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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