FDA-Device2026-03-18Class IIPROCESSING DEFECT

Beckman Coulter DxC 700 AU analyzer recalled for software errors causing result delays

OTHERNationwide distributionMedical devices

What this means

Certain Beckman Coulter DxC 700 AU clinical chemistry analyzers with specific software may stop working properly if left running for more than 15 minutes. The system will display database errors and stop analyzing patient samples. A technician from Beckman Coulter must visit your facility to install a software fix.

Check if your DxC 700 AU serial number matches the recall list
Contact Beckman Coulter to schedule a technician visit for the software update
Do not rely on this analyzer until the fix is applied

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

Adults

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

142

Manufactured in

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

Products

DxC 700 AU, REF: B86444, B86446

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1552-2026

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