Alerte De Sécurité sur Trade name: CONTROL IMMUNODIAGNOSTICO VITROS * FOR HBsAg. ANVISA registry number: 10132590637. Risk class: IV. Product code 6800598. Lots affected and imported in Brazil: 0860, 0870, 0880, 0890, 0908. Lot lot affected: 352 units.

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.

According to company information: This is a situation in which the use of the product is not likely to cause adverse health consequences. Action required of laboratories that have the affected lot: • Discontinue use and discard the remaining inventory of affected batches of VITROS HBsAg Controls. (NOTE: Until you receive your replacement order, store the open-reconstituted bottles in the frozen form for up to 4 weeks.) • Forward this notification if you have provided the affected lot (s) outside your laboratory. • Place this notification next to each VITROS System that processes the VITROS Controls for HBsAg • Fill out and return the Receipt Confirmation form. If there is no alternative batch of VITROS HBsAg Controls in your inventory, it is acceptable to continue to use the affected lot (s) by following these instructions: • Control results must be within acceptable limits on the day of reconstitution (Day 1). • Store the open-reconstituted vials in the frozen form for up to 4 weeks. We recommend measuring the aliquot of the open-reconstituted material before freezing, so that several aliquots of the same vial can be used. 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