Recall Z-2336-2025— Immunotech A.S.

Name: FDA recall Z-2336-2025
Creator: U.S. Food and Drug Administration
Published: 2025-06-12

Class II · Ongoing

Class II FDA medical device recall by Immunotech A.S., initiated 2025-06-12. It names one FDA 510(k) clearance: K935013. Product: Estrone RIA Catalog Number DSL8700 UDI Code: 15099590211615 Estrone RIA is an in vitro diagnostic manual medical device used by healthcare professionals for the quantitative measurement of estrone in human serum and plasma.. Reason: 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..

Recalling firm: Immunotech A.S.
Classification: Class II
Status: Ongoing
Initiated: 2025-06-12
Firm location: Prague 10, N/A, Czech Republic

510(k) clearances named in this recall

1 on FDA's record

K935013 — DSL ESTRONE (DSL 8700)Diagnostic Systems Laboratories, Inc.·cleared 1994-06-16

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Estrone RIA Catalog Number DSL8700 UDI Code: 15099590211615 Estrone RIA is an in vitro diagnostic manual medical device used by healthcare professionals for the quantitative measurement of estrone in human serum and plasma.

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.