—#214625

Product

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

FDA product code: CGF — Radioimmunoassay, Estrone
Device class: Class 1
Medical specialty: Clinical Chemistry
510(k) numbers: K935013
Affected lot / code info: UDI: 15099590211615/Lot: 250106D, 250203C, 250203D, 250303C, 250331C, 250428C, 250526C

Why it was recalled

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.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

On June 12, 2025, Beckman Coulter issued a "Urgent: Medical Device Recall" notification via Email. On July 8, 2025, Beckman Coulter issued a updated notification to provide additional information on the health risk and actions consignees should take. Beckman Coulter ask consignees to take the following actions: 1. Beckman Coulter recommends sharing the content of this letter with your laboratory and/or medical director regarding the need to review previous patient test results. 2. Please discard any remaining inventory of effective lots per your laboratory protocols and ask for replacement. 2. Please share this information with your laboratory staff and retain this notifications as part of your laboratory Quality System documentation. If you have forwarded any of the affected product(s) listed above to another laboratory, please provide them a copy of this letter. 3. Please respond within 10 days in one of the following ways: 1. Electronically, if you received the notification via email, 2. Manually, complete and return the enclosed Response Form.

Recalling firm

Firm: Beckman Coulter Inc.
Address: 250 S Kraemer Blvd, Brea, California 92821-6232

Distribution

Distribution pattern: US: North Carolina OUS: Argentina, Austria, Belgium, Canada, France, Germany, Greece, Hungary, Italy, Netherlands

Timeline

Recall initiated: 2025-06-12
Posted by FDA: 2025-07-21
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #214625. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.