Beckman Coulter Class II Device Recall in Japan

FDA: Device Recalls Class II

Filed January 30th, 2026

Detected March 23rd, 2026

Summary

The FDA is reporting on an ongoing Class II voluntary recall initiated by Beckman Coulter Mishima K.K. in Japan for their CHEMISTRY ANALYZER AU5800 due to a software issue that could delay patient diagnosis and treatment. The recall affects 47 units distributed nationwide in the US.

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What changed

Beckman Coulter Mishima K.K. has initiated a voluntary Class II recall for their CHEMISTRY ANALYZER AU5800 (REF: B96697, B96698, B23279, B23280, B23281) due to a software issue. The problem arises when the analyzer's calibration monitor with Microsoft SQL Server 2022 Express is open for more than 15 minutes, potentially causing database errors that prevent analysis and lead to delays in patient diagnosis and treatment. This recall affects 47 units and has been distributed across the US nationwide.

While the recall is initiated by a firm in Japan, the distribution pattern indicates significant US nationwide presence. Healthcare providers and medical device manufacturers should be aware of this recall and ensure any affected units are addressed according to the firm's remediation plan. The FDA classifies this as a Class II recall, indicating that use of or exposure to a defective product may cause adverse health consequences that are temporary or medically reversible. The recall initiation date was January 30, 2026.

What to do next

Review affected Beckman Coulter CHEMISTRY ANALYZER AU5800 units
Consult firm's remediation plan for affected units
Monitor FDA communications regarding recall status

Source document (simplified)

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