Alerta De Seguridad para Commercial Name: PROBE SAMPLE Technical Name: Sample Probe ANVISA Registration Number: 80145240438 Model Affected: PROBE SAMPLE; PROBE SAMPLE S; SAMPLE PROBE

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.

Roche Diagnóstica Brasil will shortly announce its clients affected by this issue. Roche Diagnostica Brasil is organizing a schedule of evaluation visits and / or requesting information from the equipment involved in this action to its clients to identify potentially affected sample probes and to exchange the probe, if necessary. For questions and support, please contact the CEAC Service Center - 08007720295 of Roche Diagnóstica Brasil Ltda. #### Update of the field action: UPDATED ON 10/27/2017, the company presented the report of completion of the field action, with sending of necessary evidences and corrective actions.