Beckman Coulter Inc. recalls UIBC (Unsaturated Iron Binding Capacity), REF: OSR61205,

Recall date

June 26, 2025

Source

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

Recall number

Z-2264-2025

FDA classification

Class II

Brand / firm

Beckman Coulter Inc.

Sold / distributed

US: AK, AL, AR, CO, CT, DC, DE, ID, UT OUS: Algeria, Argentina, Australia, Bahrain, Bangladesh, Belarus, Belgium, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, China, Colombia, Costa Rica, Croatia, Czechia, Egypt, El Salvador, Ethiopia, Georgia, Germany, Ghana, Gibraltar, Greece, Hong Kong, Hun…

Why it was recalled

Beckman Coulter identified that the Unsaturated Iron Binding Capacity (UIBC) assay is not meeting their labeled hemoglobin interference claims of no significant interference (i.e., less than 10%) up to 200 mg/dL hemoglobin as indicated in their instructions for use. Initial internal testing confirmed that samples with low UIBC levels failed the claimed hemolysis interference specifications with reported biases up to -43.6 % UIBC when hemolyzed serum samples contained 200 mg/dL hemoglobin.

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

What was recalled

UIBC (Unsaturated Iron Binding Capacity), REF: OSR61205,