Recall Z-2152-2025— Beckman Coulter Inc.

Name: FDA recall Z-2152-2025
Creator: U.S. Food and Drug Administration
Published: 2025-06-12

Class II · Ongoing

Class II FDA medical device recall by Beckman Coulter Inc., initiated 2025-06-12. It names one FDA 510(k) clearance: K935013. Product: Estrone RIA, REF: DSL8700. Estrone RIA is an IVD used for the quantitative measurement of estrone in human serum and plasma.. Reason: 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..

Recalling firm: Beckman Coulter Inc.
Classification: Class II
Status: Ongoing
Initiated: 2025-06-12
Firm location: Brea, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K935013 — DSL ESTRONE (DSL 8700)Diagnostic Systems Laboratories, Inc.·cleared 1994-06-16

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Estrone RIA, REF: DSL8700. Estrone RIA is an IVD used for the quantitative measurement of estrone in human serum and plasma.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.