FDA Device recall Z-1553-2026
CHEMISTRY ANALYZER AU5800, REF: B96697, B96698, B23279, B23280, B23281
- FDA Device
- Class II
- ongoing
- Published 2026-03-18
On 2026-03-18 the FDA classified a Class II recall of CHEMISTRY ANALYZER AU5800, REF: B96697, B96698, B23279, B23280, B23281 by Beckman Coulter Mishima K K, citing 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: R….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1553-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-01-30 |
| Published | 2026-03-18 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Beckman Coulter Mishima K K |
| Distribution | US |
Product
CHEMISTRY ANALYZER AU5800, REF: B96697, B96698, B23279, B23280, B23281
Reason
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
Identifiers
| code_info | REF/UDI-DI/ Newer Instrument Installed with PC preinstalled with Microsoft SQL Server 2022 Express: B96697/149876665430…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 history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1553-2026%22
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