Alerta De Seguridad para Commercial name: Cobas c 111 analyzer (with and without ISE) Technical name: Biochemical analyzer ANVISA registration number: 10287410612 Hazard class: I

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) Actions when measuring time error 7002: 108000572 occur (Annex 1) I) Error Identification: If the LED lights up red / the alarm button on the right side of the instrument turns red (Fig. / 1.1), the operator must act as described in the relevant operator's manual (section "React to messages"). ) Actions to be taken by the Client / User: Whenever the error reported as "7002: 108.000.572 a software error occurred" (Fig 2 / 2.1) is listed in the message list, the following procedure must be applied: 1 (See Fig 2 / 2.1) 2. Analyze the samples being processed from the exact time the error occurred (Fig 3 and 4 / 3.1 and 4.1) All samples processed from this date and time need to be re-run 3. Restart the system 4. Re-measure all the respective sample tests in order to ensure the absence of potentially erroneous results. 2) Fill out the form contained at the end of the notification and send it to e-mail brasil.tecnovigilancia@roche.com For further questions and support, please do not hesitate to call our 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.