Alerta De Seguridad para ARCHITECT ESTRADIOL REAGENTS - Registration number ANVISA: 80146501210 - Classification of risk: II - Lots Affected: 55900UI01, 55908UI01, 55941UI00, 57929UI00, 57931UI01, 60105UI00, 55900UI00, 55908UI00, 57929UI01, 57931UI00 and 60105UI01 (MAP OF DISTRIBUTION IN ATTACHMENT)

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.

The potential health risk applies only to patients receiving Fulvestrant, which may lead to elevated estradiol levels. In the worst case scenario, falsely elevated estradiol results may lead to an incorrect assessment of the menopausal status and inadequate treatment. Tests performed as a research study showed the following results as shown below: Population that the estradiol concentration represents: Postmenopausal women Outcome of estradiol in the sample without dilution pg / mL (pmol / L): 29.14 * (106, 94) Estradiol result in the supplemented sample pg / mL (pmol / L): 85.80 (314.89)% Recovery (Interference): 294.44% Cross Reactivity: 0.23 - A sample was supplemented with 25,100 pg / Fulvestrant (25.100 pg / mL is a representative maximum concentration of Fulvestrant) -% Recovery = (result of the supplemented sample / result of the sample without dilution) X 100. -% Cross Reactivity = ((result of sample supplemented in pg / mL - result of sample without dilution in pg / mL) / Fulvestrant concentration supplemented in pg / mL) X 100. * Sample of human serum not supplemented.