Olympus AU400 Clinical Chemistry Analyzer

• • Ongoing Z-3332-2026 FDA Class II ·initiated 3 Aug 2026 ·on shared 510(k) K981743

  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.

• • Completed Z-1907-2025 FDA Class II ·initiated 30 Apr 2025

  A manufacturing defect in the sample probe (S probe). The corners of the tip of the defective S probe are rounded and chamfered, which can prevent the proper formation of the "air layer" required for normal dispensing. The air layer is the air space that separates the cleaning water filled in the probe from the sample sucked into the probe. Maintaining this air space prevents the cleaning water and the sample from mixing. In the defective S probe, the "air layer" was not properly formed, causing the cleaning water and the sample to mix diluting the sample. As a result, the sample mixture dispensed into the cuvette has a lower concentration than the original sample, and the analyte concentration measured is lower than expected results.

• 2 recalls, same reason

  • Terminated Z-0152-2014 FDA Class II ·initiated 9 Sep 2013 ·on shared 510(k) K981743
  • Terminated Z-0153-2014 FDA Class II ·initiated 9 Sep 2013 ·on shared 510(k) K981743

  The recall was initiated because Beckman Coulter has confirmed that some AU Clinical Chemistry Analyzer ISE units can experience premature ISE REF (Reference) valve failure. Premature valve failure can be detected by the presence of air bubbles in the ISE REF solution tubing on the ISE unit. If air bubbles are present, accuracy of the ISE test results may be affected.

• • Terminated Z-0974-2012 FDA Unclassified (pre-2012) ·initiated 12 Jul 2010 ·on shared 510(k) K981743

  The recall was initiated because Beckman has confirmed that the AU Clinical Chemistry Analyzers may experience cuvette overflow.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K981743 ↗

FDA Product Code

CKB

Device Class

Class II

Regulation

21 CFR Part 862.1020

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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