Official recall record
Systems/units containing affected software/SQL BECKMAN COULTER CHEMISTRY ANALYZER AU480 REF / UDI-DI code: B96692 / 14987666542965 B9669
- Issuing authority
- US FDA — Medical Devices
- Alert date
- 2026-08-03
- Country of alert
- Japan
- Alert level
- Class II
- Alert type
- recall
- Barcode (EAN/GTIN)
- 14987666542965
- Brand on record
- Beckman Coulter Mishima K.K.
- Product category
- Medical Device
What the authority reported
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.
What to do
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Verify at the source:
US FDA — Medical Devices — official record →
Record last checked against the registry on 2026-10-22.
Record last checked against the registry on 2026-10-22.
Other recalls from this brand
- 2026-01-30 · US FDA — Medical Devices
CHEMISTRY ANALYZER AU5800, REF: B96697, B96698, B23279, B23280, B23281 - 2026-01-30 · US FDA — Medical Devices
DxC 700 AU, REF: B86444, B86446 - 2025-04-30 · US FDA — Medical Devices
Sample probe sucks a sample dispensed into a tube or cup and discharges the appropriate amount into a cuvett
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