Rack Tray Technical name: Rack Tray, part of the equipment listed in the field action notification SBN-CPS-2016-013 ANVISA registration number: 3378900001 Hazard class: III 의 안전성 경고

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.

Actions to be taken by the customer / user: 1) Please ensure that the updated racks cleaning procedure, attached to this field action notification as "Addendum - Cleaning Rack Mounts", shall be followed users / operators responsible for cleaning. 2) Please fill in the form contained at the end of this notification and send to email 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.