CHEMISTRY ANALYZER AU5800, REF: B96697, B96698, B23279, B23280, B23281
FDA Recall #Z-1553-2026 — Class II — January 30, 2026
Product Description
CHEMISTRY ANALYZER AU5800, REF: B96697, B96698, B23279, B23280, B23281
Reason for Recall
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
Recalling Firm
Beckman Coulter Mishima K.K. — Sunto-Gun, N/A
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
47
Distribution
US Nationwide distribution including in the states of NE, WA, PA, CA, AZ, NC, TX, NV, CT, AL, NJ, TN, MT, ID, GA, SC, OH, KS, WI, HI, FL, VA, MI, NH, ME, NY, OR, LA, PR, MN, IL, MD, MO, MS, OK, AR.
Code Information
REF/UDI-DI/ Newer Instrument Installed with PC preinstalled with Microsoft SQL Server 2022 Express: B96697/14987666543016/2025061442, 2025061446, 2025061452, 2025061454, 2025061464, 2025071479, 2025071488, 2025081513, 2025081516, 2025091536, 2025091538, 2025091543, 2025091559, 2025091561, 2025111598, 2025111602, 2025111604, 2025111605, 2025111606, 2025121618, 2025121622, 2025121623. B96698/14987666543023/2025061449, 2025061451, 2025061457, 2025061467, 2025071475, 2025071476, 2025071478, 2025071481, 2025071495, 2025071497, 2025081503, 2025081524, 2025091539, 2025091549, 2025091551. Older Instrument Replaced with PC preinstalled with Microsoft SQL Server 2022 Express: B23279/14987666541296/2014011316, 2014071647, 2014121858, 2014121906. B23280/14987666541302/2016022593. B23281/14987666541319/5094354. B96697/14987666543016/2019074683. B96698/14987666543023/2017063377, 2019114891, 2024101288
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated