Estrone RIA recall (Immunotech A.S.)
Medical deviceClass IIOngoing
Summary: Immunotech A.S. is recalling Estrone RIA, REF: DSL8700. Reason: 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.
What is being recalled
Estrone RIA, REF: DSL8700
Why
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.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
Worldwide - US Nationwide distribution in the state of NC and the countries of Germany, Argentina, Netherlands, Hungary, Austria, Belgium, France, Italy. (states named: North Carolina)
How to tell if yours is affected
UDI: 15099590211615. Lot(Expiration): 251013C(2025-12-30), 251110C(2026-01-27)
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-1369-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | December 15, 2025 |
| Reported | February 25, 2026 |
| Company | Immunotech A.S. |
| Company location | Prague 10, Czech Republic |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 160 |
More recalls from Immunotech A.S. · all medical device recalls · recalls from December 2025