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Low risk Medical DevicesClass II

Immunotech Estrone RIA Test Kit Recall

Estrone RIA, REF: DSL8700

Updated December 15, 2025

Certain lots of Immunotech's Estrone RIA test kit (model DSL8700) may rarely produce falsely high patient results. The risk of injury is very remote and occurs only in rare cases.

Is the Immunotech A.S. recalled? Yes. This product was recalled by FDA on December 15, 2025. Details below.

What is recalled

Estrone RIA, REF: DSL8700, manufactured by Immunotech A.S. Affected lots are listed by the manufacturer; check your kit's lot number against Immunotech's recall notice.

Am I affected

You're affected if you own or use an Estrone RIA kit (model DSL8700) from Immunotech A.S. Check your kit's lot number against the affected lot list provided by Immunotech.

What to do right now

Contact Immunotech A.S. to verify whether your Estrone RIA kit lot is affected and for instructions on next steps. Do not discard the kit until you receive guidance.

The hazard

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.

Brands affected

Immunotech A.S.
Source
FDA
Category
Medical Devices
Recall ID
fda-Z-1369-2026
Classification
Class II
Recalled
December 15, 2025
Read the official notice

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