FDA recall Z-1553-2026

Beckman Coulter Mishima K.K. · Class II · device

Product

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

Reason for recall

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

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.

Key facts

Status
Ongoing
Initiation date
2026-01-30
Report date
2026-03-18
Voluntary/Mandated
Voluntary: Firm initiated
Location
Sunto-Gun, N/A, Japan

Primary source

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