Immunotech A.S.: 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 measureme

Hazard

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.

Details from the source

Reason for recall: 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. Distribution: 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. Quantity: 279 units Lot/code info: Catalog Number DSL8700 UDI Code: 15099590211615 Serial/Lot Numbers: 241014D 241111C 241209C 241209D 250106C 250106D 250203C

UPC codes

15099590211615

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.