Beckman Coulter AU5800 chemistry analyzer recalled for software errors causing delayed test results
Beckman Coulter AU5800 chemistry analyzers with certain software configurations may experience errors that prevent the system from opening calibration databases after running for more than 15 minutes. When this happens, the analyzer stops working and requires a service technician to fix it, which can delay patient test results and treatment.
From the FDA notice · Read the official notice ↗ · All Beckman Coulter recalls
What to do
- If you operate an AU5800 analyzer, contact Beckman Coulter service immediately to determine if your unit is affected.
- Do not ignore database error messages—they indicate the problem has occurred.
- Schedule a service visit to apply the software fix before the system fails during patient testing.
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- CHEMISTRY ANALYZER AU5800, REF: B96697, B96698, B23279, B23280, B23281
- Sold in
- Nationwide
- Made for
- All ages (under 100 years)
This recall covers 2 products — see all of them.
Details
- Units affected
- 47
- Illnesses reported
- None reported
- Manufactured in
- 454-32, Higashino; Nagaizumi-Cho, Sunto-Gun, N/A, Japan
- Classification
- Class II
- Recall number
- Z-1553-2026
In the FDA's words
- Description
- CHEMISTRY ANALYZER AU5800, REF: B96697, B96698, B23279, B23280, B23281 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 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 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. Affected quantity: 47
- 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
2 products in this recall
Beckman Coulter DxC 700 AU and AU5800 analyzers recalled for delayed results risk
Beckman Coulter is recalling two clinical chemistry analyzer models, the DxC 700 AU and the AU5800, because the calibration monitor PC can show database errors if it is left open for more than 15 minutes. When this happens, the system can stop analyzing samples, which may delay test results, diagnosis, or patient treatment. No injuries have been reported.
The agency lists each product separately. Check every one you might have.
- DxC 700 AU, REF: B86444, B86446Z-1552-2026 · 142
- CHEMISTRY ANALYZER AU5800, REF: B96697, B96698, B23279, B23280, B23281 (this page)Z-1553-2026 · 47