Immunotech A.S.: Medical Device Recall in 2026 - (Recall #: Z-1369-2026)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2026.

Data Source: FDA.

Product Description:

Estrone RIA, REF: DSL8700

Product Classification:

Class II

Date Initiated: December 15, 2025

Date Posted: February 25, 2026

Recall Number: Z-1369-2026

Event ID: 98219

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.

Status: Ongoing

Product Quantity: 160

Code Information:

UDI: 15099590211615. Lot(Expiration): 251013C(2025-12-30), 251110C(2026-01-27)

Distribution Pattern:

Worldwide - US Nationwide distribution in the state of NC and the countries of Germany, Argentina, Netherlands, Hungary, Austria, Belgium, France, Italy.

Voluntary or Mandated:

Voluntary: Firm initiated