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Recall Observatory FDA recall evidence

Device product

Estrone RIA Catalog Number DSL8700 UDI Code: 15099590211615 Estrone RIA is an in vitro diagnostic manual medical device used by healthcare professionals for the quantitative measurement of estrone in human serum and plasma.

Z-2336-2025

June 12, 2025

Class II

Product summary

Firm
Immunotech A.S.
Event
Event 97090
Status
Ongoing
Classification
Class II
Quantity
279 units
Official record key
device-enforcement:Z-2336-2025

Official wording

Reason: Estrone RIA kit lots may rarely give falsely high patient results which might cause Temporary injury of Remote probability or rarely give falsely low patient results which might cause Permanent injury of Remote probability. Only in some (very rare) cases may the issue occur.

Code information: Catalog Number DSL8700 UDI Code: 15099590211615 Serial/Lot Numbers: 241014D 241111C 241209C 241209D 250106C 250106D 250203C

Distribution pattern: Worldwide - U.S. Nationwide distribution in the states of NC and the countries of Argentina, Austria, Belgium, Canada, France, Germany, Greece, Hungary, Italy, and Netherlands.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Estrone RIA kit lots may rarely give falsely high patient results which might cause Temporary injury of Remote probability or rarely give falsely low patient results which might cause Permanent injury of Remote probability. Only in some (very rare) cases may the issue occur.