Beckman Coulter, Inc. recalls DxI 9000 Access Immunoassay Analyzer C11137

Recall date

May 7, 2025

Source

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

Recall number

Z-1996-2025

FDA classification

Class II

Brand / firm

Beckman Coulter, Inc.

Sold / distributed

Worldwide - US Nationwide distribution in the states of AR, CA, FL, GA, HI, ID, IL, IN, KY, LA, ME, MI, NH, NJ, NY, OH, OK, OR, PA, SD, TN, TX, WA, WI and the countries of Algeria, Australia, Austria, Belgium, Brazil, C¿te d'Ivoire, Croatia, Czechia, France, Germany, Hungary, India, Ireland, Israel…

Why it was recalled

Analyzer has calibration issues where curves switched from passed to failed due to system errors during aspiration. This anomaly causes erroneous results and delays if unnoticed. RLU values may be misinterpreted as valid measurements by LIS.

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

What was recalled

DxI 9000 Access Immunoassay Analyzer C11137