Alerta De Seguridad para VITROS IMMUNODIAGNOSIS CALIBRATOR * ECi FOR T4TOTA L, Registration nº 10132590390 and VITROS IMUNODIAGNOSTIC REAGENT KIT * ECi FOR TOTAL T4, Registration nº 10132590400 - lot 1590 - See Annex 1 - Distribution List

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 company informs that if the service identifies this problem, the VITROS ® System may have had a calibration failure or have presented lower than expected quality control results after the successful calibration of Lot 1590. If the control results are negatively biased, suspect that patient outcomes have been affected, consult your medical director in your laboratory to address any concerns you may have regarding the results of previously reported patients. The company informs that this is a situation in which the use or exposure to the affected product may cause temporary or clinically reversible adverse health consequences, or where the likelihood of a serious adverse health consequence is remote