Alerta De Seguridad para CONTOUR TS Blood Glucose Test Strip - BAYER - Record 80384380008. CONTOUR TS BLOOD GLUCOSE TEST STRIPS - Schering - Registration 80146460011. Lots - As per attachment.

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.

Bayer states that it conducted extensive testing (described in the health risk assessment, modeling data and sensitivity analyzes) and determined that the problem potentially affects 25- and 10-strip flasks, but does not affect flasks with 50 units. It points out that, as documented in the health risk assessment, modeling data with sensitivity analyzes, and external expert review, Bayer is confident that the potential downward deviation of these products does not endanger the health of users. Bayer is evaluating corrective measures to definitively resolve the deviation issue down. As a consequence of the acquisition of Schering do Brasil, as well as the transfer of the records of the products to Bayer S / A, it informs the imported lots affected. Anvisa accompanies this action. #### UPDATE: 04/09/2012 - The company presents a validation report of the new packaging of reagent strips, which constitutes a permanent corrective measure for the problem indicated, through dossier 0714259 / 12-5. ####