Immunotech A.S. recalls Estrone RIA Catalog Number DSL8700 UDI Code: 15099590211615 Estrone RIA is an in vi…

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.

On 06/12/2025, the firm sent an "URGENT MEDICAL DEVICE RECALL" Letter to customers informing them that Beckman Coulter determined that the Estrone RIA kit might be affected by an isolated coated tubes inhomogeneity issue causing falsely elevated results or falsely decreased results. Customers are instructed to: Beckman Coulter recommends sharing the content of the Recall Letter with their laboratory and/or medical director regarding the need to review previous patient test results. Note- All affected product have expired (expiry dates 12/31/2024 thru 04/22/2025) For questions, contact Customer Support Center: Website: http://www.beckmancoulter.com Email: imunochem@beckman.com

• FDA enforcement recordOfficial FDA database entry for Z-2336-2025
• 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 Immunotech A.S.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.