FDA DevicesClass II
CHEMISTRY ANALYZER AU5800, REF: B96697, B96698, B23279, B23280, B23281
Published: March 18, 2026Recall ID: Z-1553-2026Category: devicesCountry: US
Reason for Recall / Hazard
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
Product Description & Identification
CHEMISTRY ANALYZER AU5800, REF: B96697, B96698, B23279, B23280, B23281
Additional Source Details
| Field | Value |
|---|---|
| City | Sunto-Gun |
| State | N/A |
| Event id | 98346 |
| Address 1 | 454-32 |
| Address 2 | Higashino; Nagaizumi-Cho |
| Code info | 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 |
| Postal code | N/A |
| Report date | 20260318 |
| Product type | Devices |
| Product quantity | 47 |
| 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 |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260130 |
| Initial firm notification | Letter |
| Center classification date | 20260311 |
Overview
- Recalling FirmBeckman Coulter Mishima K.K.
- StatusOngoing
- Risk LevelClass II
- DistributionUS 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.