Beckman Coulter Mishima K.K. recalls DxC 700 AU, REF: B86444, B86446

Recall date

January 30, 2026

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1552-2026

FDA classification

Class II

Brand / firm

Beckman Coulter Mishima K.K.

Sold / distributed

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.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

DxC 700 AU, REF: B86444, B86446