Dsl Estrone (Dsl 8700)

• • Ongoing Z-1369-2026 FDA Class II ·initiated 15 Dec 2025

  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.

• • Ongoing Z-2336-2025 FDA Class II ·initiated 12 Jun 2025

  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.

• • Ongoing Z-2152-2025 FDA Class II ·initiated 12 Jun 2025

  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.

• • Terminated Z-1685-2011 FDA Unclassified (pre-2012) ·initiated 22 Apr 2010

  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.

510(k) Number

K935013 ↗

FDA Product Code

CGF

Device Class

Class I

Regulation

21 CFR Part 862.1280

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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