FDA-Device2026-02-25Class II
Estrone RIA, REF: DSL8700
Immunotech A.S.
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.
Sold states
Worldwide - US Nationwide distribution in the state of NC and the countries of Germany, Argentina, Netherlands, Hungary, Austria, Belgium, France, Italy.
Affected count
160
Manufactured in
Radiova 1, Prague 10, Czech Republic
Products
Estrone RIA, REF: DSL8700
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1369-2026Original summary
Estrone RIA, REF: DSL8700 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. UDI: 15099590211615. Lot(Expiration): 251013C(2025-12-30), 251110C(2026-01-27) Distribution: Worldwide - US Nationwide distribution in the state of NC and the countries of Germany, Argentina, Netherlands, Hungary, Austria, Belgium, France, Italy. Affected quantity: 160
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