Immunotech A.S. Issues Recall for Estrone RIA Kits Over Inaccurate Test Results

What Happened

Immunotech A.S. has initiated a voluntary recall of specific lots of its Estrone RIA diagnostic kits. The recall was prompted by the discovery that affected kits may rarely produce falsely high patient results. According to the company, while the probability of occurrence is remote, these inaccuracies could potentially lead to temporary injury for patients.

Which Products Are Affected

The recall impacts the following medical device:

• Product Name: Estrone RIA
• Reference Number: DSL8700
• UDI: 15099590211615
• Affected Lots (Expiration Dates): 251013C (2025-12-30) and 251110C (2026-01-27)
• Quantity: 160 units

Distribution of these units is worldwide, including nationwide distribution within the United States (specifically North Carolina), as well as Germany, Argentina, Netherlands, Hungary, Austria, Belgium, France, and Italy.

What You Should Do

The firm initiated the recall process by sending notification letters to affected customers. Laboratories and healthcare providers should immediately check their inventory for the specified lot numbers and follow the instructions provided in the firm’s notification letter regarding the handling or return of the affected kits.

Why This Matters

Reliable diagnostic results are essential for proper patient management. Falsely elevated estrone levels could lead to misdiagnosis or inappropriate clinical interventions, though the risk of serious harm is considered low and the probability of the defect occurring is remote.

Source

Information provided by the FDA under recall number Z-1369-2026.