Estrone RIA, REF: DSL8700
- Company
- Immunotech A.S. Radiova 1 Prague
- Recall Initiated
- December 15, 2025
- Posted
- February 13, 2026
- Recall Number
- Z-1369-2026
- Quantity
- 160
Reason for Recall
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.
Distribution
Worldwide - US Nationwide distribution in the state of NC and the countries of Germany, Argentina, Netherlands, Hungary, Austria, Belgium, France, Italy.
Lot / Code Info
UDI: 15099590211615. Lot(Expiration): 251013C(2025-12-30), 251110C(2026-01-27)
Root Cause
Equipment maintenance
Action Taken
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