HIGH

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

Quick Facts at a Glance

Recall Date
January 30, 2026
Hazard Level
HIGH
Brand
Beckman Coulter Mishima K.K.
Geographic Scope
1 states

Hazard Information

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

What You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Beckman Coulter Mishima K.K. or your healthcare provider for instructions. Notification method: Letter

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Full Description

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. Classification: Class II. 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.

View Original Recall on FDA - Medical Devices

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Product Classification

Product Details

Model Numbers
REF/UDI-DI/ Newer Instrument Installed with PC preinstalled with Microsoft SQL Server 2022 Express: B96697/14987666543016/2025061442
2025061446
2025061452
2025061454
2025061464
+15 more
Affected States
ALL
Report Date
March 18, 2026
Recall Status
ACTIVE

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