Alerte De Sécurité sur Trade name: Kit Nat HIV / HCV / HBV Bio-Manguinhos //. Technical Name: HIV VIRUS NUCLEIC ACID, HBV AND HCV //. ANVISA registration number: 80142170025 //. Risk class: IV - Maximum risk //. Batch numbers affected: 16PNB075Z and 16PNB076Z

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.

Do not use the BioPlus BH-HCV / HBV Batch Bio-Kit 16PNB075Z and 16PNB076Z to avoid invalidation and repetition of routines. If you wish to notify technical complaints and adverse events use the following channels: Notivisa: Notices of adverse events (AE) and technical complaints (QT) for products subject to Sanitary Surveillance should be made through the NOTIVISA System. To access the System, you must register and select the Health Professional option, if you are a liberal professional or the Institution / Entity option, if you are a professional of an institution / entity. Technovigilance System: Patient or citizen can notify through the Technovigilance System / SISTEC access through the link