Alerta De Seguridad para ELISA CRUZI - Lot: 61207 - Reference 35117, Anvisa Registry # 10158120521 Contact the Owner

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.

Due to the problem presented, considering that the batch involved, exhibits a profile outside the specifications and can compromise the routine of the customers, the Company decided to stop the commercialization, thus promoting the collection of the batch in question. If you have the listed lot in your inventory, contact your local representative or manufacturer by calling 0800.264848 - option 2. - Department of Scientific Support. ANVISA through the Technovigilance Unit will be following the case, in order to ensure that the health products marketed in Brazil have the safety and efficacy necessary to the good performance of the product. Update: On September 27, 2007, the Company presents the UTVIG, a copy of the certificate of destruction of the kits collected in the market.