Immunotech A.S.: Medical Device Recall in 2025 - (Recall #: Z-2336-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: June 12, 2025

Date Posted: August 27, 2025

Recall Number: Z-2336-2025

Event ID: 97090

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.

Status: Ongoing

Product Quantity: 279 units

Code Information:

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

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.

Voluntary or Mandated:

Voluntary: Firm initiated