FDA recall Z-2336-2025

Immunotech A.S. · Class II · device

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 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

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.

Key facts

Status
Ongoing
Initiation date
2025-06-12
Report date
2025-08-27
Voluntary/Mandated
Voluntary: Firm initiated
Location
Prague 10, N/A, Czech Republic

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2336-2025