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Beckman Coulter Chemistry Analyzers
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MEDICAL DEVICE RECALLMODERATE

Beckman Coulter Chemistry Analyzers

Beckman Coulter is recalling chemistry analyzers due to a software error that may cause system delays and impact patient diagnosis.

What to do

Contact Beckman Coulter service to schedule a software update to resolve the database communication error.

Posted
Updated
Recall No.
Z-1553-2026
Agency
Firm
Beckman Coulter Mishima K.K.
Recall ID
98346
Status
ONGOING

Why it was recalled

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

How to identify it

UPC 14987666543016 2025061442 2025061446 2025061452 2025061454 2025061464 2025071479 2025071488

CHEMISTRY ANALYZER AU5800, REF: B96697, B96698, B23279, B23280, B23281

Where it was sold

Distributed in US.

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Editorial summary by Recall Canary · last updated 2026-06-05 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification