Home / Recalls / Immunotech A.S. / Z-2336-2025

Z-2336-2025 Class II Ongoing

Recalled by Immunotech A.S. — Prague 10, N/A

Recall Details

Product Type: Devices
Report Date: August 27, 2025
Initiation Date: June 12, 2025
Termination Date: N/A
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 279 units

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.

Distribution Pattern

Worldwide - U.S. Nationwide distribution in the states of NC and the countries of Argentina, Austria, Belgium, Canada, France, Germany, Greece, Hungary, Italy, and Netherlands.

Code Information

Catalog Number DSL8700 UDI Code: 15099590211615 Serial/Lot Numbers: 241014D 241111C 241209C 241209D 250106C 250106D 250203C