Medical Device Recall: Estrone RIA, REF: DSL8700. Estrone RIA is an IVD used for the quantitative measurement of estrone in human serum and plasma.
Beckman Coulter Inc. · June 12, 2025
Reason for Recall
A specific lot of bovine serum albumin (BSA) used for manufacturing of coated tubes (CT) that are included in the Estrone RIA kit lots caused different affinity of manufactured coated tubes to patient samples, causing falsely increased assay results for the impacted Estrone RIA kits.
Distribution
US: North Carolina OUS: Argentina, Austria, Belgium, Canada, France, Germany, Greece, Hungary, Italy, Netherlands
Quantity Affected
496 units
Source: FDA (openFDA Device Enforcement)
Recall number: Z-2152-2025
Status: ongoing
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