FDA-Device2026-03-18Class IIPROCESSING DEFECT

Beckman Coulter AU5800 chemistry analyzer recalled for software errors causing delayed test results

OTHERNationwide distributionMedical devices

What this means

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.

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.

The agency's original wording

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

Intended for

All ages

Illnesses reported

None reported

Sold states

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 count

Manufactured in

454-32, Higashino; Nagaizumi-Cho, Sunto-Gun, N/A, Japan

Products

CHEMISTRY ANALYZER AU5800, REF: B96697, B96698, B23279, B23280, B23281

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1553-2026

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