Recall Z-3332-2026— Beckman Coulter Mishima K.K.

Name: FDA recall Z-3332-2026
Creator: U.S. Food and Drug Administration
Published: 2026-08-03

Class II · Ongoing

Class II FDA medical device recall by Beckman Coulter Mishima K.K., initiated 2026-08-03. It names one FDA 510(k) clearance: K981743. Product: Systems/units containing affected software/SQL BECKMAN COULTER CHEMISTRY ANALYZER AU480 REF / UDI-DI code: B96692 / 14987666542965 B96693 / 14987666542972 B12183 / 14987666540671 The AU480 Chemistry Analyzer measure analytes in samples, in combination with appropriate reagents, calibrators, quality control (QC) material, and other accessories. This system is for in vitro diagnostic use only.. Reason: Certain AU480 chemistry analyzers, with Windows 10 IoT Enterprise 2021 LTSC PCs, may output the message System Stopped By Fatal Error: DBConnectionError AlarmDB when launching the instrument software, using PC pre-installed with Microsoft SQL Server 2022 Express. When this occurs, AlarmDB becomes unreadable and the instrument software cannot be started. This causes a delay in obtaining patient results..

Recalling firm: Beckman Coulter Mishima K.K.
Classification: Class II
Status: Ongoing
Initiated: 2026-08-03
Firm location: Sunto-Gun, Japan

510(k) clearances named in this recall

1 on FDA's record

K981743 — OLYMPUS AU400 CLINICAL CHEMISTRY ANALYZEROlympus America, Inc.·cleared 1998-06-09

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Systems/units containing affected software/SQL BECKMAN COULTER CHEMISTRY ANALYZER AU480 REF / UDI-DI code: B96692 / 14987666542965 B96693 / 14987666542972 B12183 / 14987666540671 The AU480 Chemistry Analyzer measure analytes in samples, in combination with appropriate reagents, calibrators, quality control (QC) material, and other accessories. This system is for in vitro diagnostic use only.

Reason for recall

Certain AU480 chemistry analyzers, with Windows 10 IoT Enterprise 2021 LTSC PCs, may output the message System Stopped By Fatal Error: DBConnectionError AlarmDB when launching the instrument software, using PC pre-installed with Microsoft SQL Server 2022 Express. When this occurs, AlarmDB becomes unreadable and the instrument software cannot be started. This causes a delay in obtaining patient results.

Data sourced from openFDA. This site is unofficial and independent of the FDA.