Radioimmunoassay, Estrone

Estrone RIA, REF: DSL8700

The affected Estrone RIA kit lots may rarely give falsely high patient results which might cause Temporary injury of Remote probability. Only in some (very rare) cases may the issue occur.

Estrone RIA Catalog Number DSL8700

Estrone RIA kit lots may rarely give falsely high patient results which might cause Temporary injury of Remote probability or rarely give falsely low patient results which might cause Permanent injury of Remote probability. Only in some (very rare) cases may the issue occur.

Estrone RIA, REF: DSL8700.

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.

Estrone Radioimmunoassay (RIA) Kit, DSL-8700.

Beckman Coulter has confirmed that eight Estrone RIA kit (Ref DSL 8700) lots are inaccurately calibrated to the firm's internal reference calibrator. Lots 992637, 100115A, 100205A, 100205RA, and 100226A have now expired and should not be in active use any more.