Immunotech A.S. recalls Estrone RIA

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.

On 12/15/2025, Beckman Coulter emailed recall notices to customers who were informed of the following: 1) Discard any remaining inventory of affected lots per your laboratory protocols and ask for replacement. 2) Firm recommends sharing the content of this letter with your laboratory and/or medical director. 3) If you have forwarded any of the affected products to another laboratory, provide them a copy of this letter. 4) Complete and return the response form via email to QACZ@beckman.com Questions can be sent to the firm via email at imunochem@beckman.com

• FDA enforcement recordOfficial FDA database entry for Z-1369-2026
• 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.