Official recall record
CHEMISTRY ANALYZER AU5800, REF: B96697, B96698, B23279, B23280, B23281
- Issuing authority
- US FDA — Medical Devices
- Alert date
- 2026-01-30
- Country of alert
- Japan
- Alert level
- Class II
- Alert type
- recall
- Barcode (EAN/GTIN)
- 14987666543016
- Brand on record
- Beckman Coulter Mishima K.K.
- Product category
- Medical Device
What the authority reported
A delay in results may occur. When clinical chemistry analyzer calibration monitor with PC installed with Microsoft SQL Server 2022 Express is open beyond15 minutes may lead to: Reagent Blank and calibration databases not opening errors: CAL History DB Open Error.., RB History DB Open Error..; system will stop analyzing, firm service must visit to apply software solution; may lead to delay in diagnosis and/or patient treatment
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 2026-05-31.
Record last checked against the registry on 2026-05-31.
Other recalls from this brand
- 2026-08-03 · US FDA — Medical Devices
Systems/units containing affected software/SQL BECKMAN COULTER CHEMISTRY ANALYZER AU480 REF / UDI-DI code: - 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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