ARCHITECT TOXO IgG REAGENT KIT - Registration 80146501513 - Lots Affected: 15070LI00 and 15070LI01. 의 안전성 경고

Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.

A false reactive result for the Toxo IgG test would lead to a misdiagnosis that the patient would be immune to Toxoplasmosis. In the case of a pregnant patient, this type of diagnosis could avoid monitoring during pregnancy, which would lead to loss of early detection of infection and subsequent therapeutic intervention. There is potential for occurrence of results from falsely reactive patients at an estimated incidence of 2.65%. According to the Company's Action Plan, the term for this Field Action is OUT / 2012. Anvisa accompanies this Action.