Alerte De Sécurité sur Product name: Vidas Anti HBS Total II (60 T) Technical name: Lives Anti HBS Total II Registration number ANVISA: 1058120684 Hazard Class: IV Affected Model: Not applicable Serial Numbers Affected: 1005262630

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.

1- Distribute the information of possible false result to the team members of the laboratories, including other institutions to which they have sent the kits. 2- Return the units that are still in the stock of the customers, units that composed the AWB # 2AWN533, in question, since only these had problems in the transportation to Brazil. 3- Discuss with the Director of the laboratory what decision will be taken regarding the analyzes performed previously with the units received from this lot (which were part of the AWB mentioned above). If you wish to retake the tests contact bioMérieux Brasil. 4- Complete the form to receive the information of recollection and send it back to the Integrated Customer Service of bioMérieux Brazil. ### Update of the field action: UPDATED ON 10/23/2017, the company presented the report of completion of the field action proving the sending of the safety notice to the client with evidence of science and all actions completed.