Reported Oct 7, 2026 · Ongoing · Updated Oct 13, 2026
Systems/units containing affected software/SQL BECKMAN COULTER CHEMISTRY ANALYZER AU480 REF / UDI-DI code: B96692 /…
Beckman Coulter Mishima K.K.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Beckman Coulter Mishima K.K. · 454-32 · Sunto-Gun · N/A
Is this the product you have?
- Systems/units containing affected software/SQL BECKMAN COULTER CHEMISTRY
- ANALYZER AU480 REF / UDI-DI codeB96692 / 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
- Lot codes and dates
5 of 5 products
Products covered by this recall Model / number Barcodes Product as published — Item Numbers / UDI-DI codes B9669214987666542965UDI-DI code: 14987666542965 B9669314987666542972UDI-DI code: 14987666542972 B1218314987666540671UDI-DI code: 14987666540671 N3151400UDI-DI code: Due to the age of the device and the fact that it has exceeded its storage period, the UDI number is not available.) - Amount recalled
- 492 units
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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