Immunotech A.S. FDA Recalls

2 recalls on file across devices, 0 of them Class I and 2 still open. This firm is not matched to a listed company.

Newest first

Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Product	Reason	Class	Initiated
Estrone RIA, REF: DSL8700Class IIDec 15, 2025The affected Estrone RIA kit lots may rarely give falsely hi	The affected Estrone RIA kit lots may rarely give falsely high patient results which might cause Temporary inj	Class IIDevices	Dec 15, 2025
Estrone RIA Catalog Number DSL8700 UDI Code: 15099590211615 Estrone RIA is an in vitro diagnostic manual medical devClass IIJun 12, 2025Estrone RIA kit lots may rarely give falsely high patient re	Estrone RIA kit lots may rarely give falsely high patient results which might cause Temporary injury of Remote	Class IIDevices	Jun 12, 2025