Reported Feb 25, 2026 · Ongoing

Estrone RIA, REF: DSL8700

Immunotech A.S.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Immunotech A.S. · Radiova 1 · Prague 10 · N/A

Is this the product you have?

  • Estrone RIA
  • REFDSL8700
Lot codes and dates
  • UDI15099590211615
  • Lot(Expiration)
    • 251013C(2025-12-30)
    • 251110C(2026-01-27)
Amount recalled
160

Where it was sold

  • Nationwide
  • NC

Why it was recalled

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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 6:56 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.