Beckman Coulter Inc. recalls Estrone RIA

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.

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.

• FDA enforcement recordOfficial FDA database entry for Z-2152-2025
• FDA 510(k) clearance · K935013The device's official FDA premarket clearance record
• FDA device classification · CGFOfficial FDA classification for this device type
• CFR regulation · 21 CFR 862.1280The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Beckman Coulter Inc.Search for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.