Safety Alert for Trade name: Cobas 6500 - u 601 eu 701. Technical name: Instrument for urinalysis. ANVISA registration number: 80712710007. Risk class: III. Model Affected: N / A. Serial numbers affected: See attached list on Anvisa portal - link: http://portal.anvisa.gov.br/informacoes-tecnicas13/-/asset_publisher/WvKKx2fhdjM2/content/alerta-2471-tecnovigilancia-roche-foco-cirurgico- The following table summarizes the results of this study: - illumina-sample incompatibility / 33868? p_p_auth = PAWpHtof & inheritRedirect; = false & redirect; = http% 3A% 2F% 2Fportal.anvisa.gov.br% 2Final-techniques13% 3Fp_p_auth% 3DPAWpHtof% 26p_p_id% 3D101_INSTANCE_WvKKx2fhdjM2% 26p_p_lifecycle% 3D0% 26p_p_state% 3Dnormal% 26p_p_mode% 3Dview% 26p_p_col_id% 3Dcolumn-3% 26p_p_col_pos% 3D1% 26p_p_col_count% 3D5

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 client / user: We request that you perform the procedure described below to verify the proper function of the systems. >>> Checks to be carried out by the operator: Please check the details panel of the result details screen, if the Sample ID, Rack ID and Rack position position) correspond to the Sample ID, Rack ID and Rack position physically inserted. Here's how: 1. Choose Routine> Manage Test Results 2. In the main panel, choose a sample entry. 3. In the details pane, choose the sample button at the top of the panel. If the Sample ID, Rack ID, and Rack position are not consistent with the physical condition, the test result should not be used and the sample reprocessed. If the problem occurs, contact Roche Technical Support (CEAC - 08007720295). >>> Verification of analyzer operation: Note: This test must be performed with bar code labels on the sample tubes, even if, in the normal routine, bar code labels are not used for sample identification. 1. Prepare 15 tubes labeled with bar codes and filled with water. 2. Place the tubes in 3 gray racks and place them in the rack tray. 3. Place the rack tray in the input buffer.  The measurement starts automatically. 4. After the measurements, verify that: a. Sufficient results are generated for all tubes and are displayed correctly. B. Sample ID (tube bar code), Rack ID and Rack position are displayed correctly according to the configuration of the 3 racks, especially double check the Rack ID. w. No sample ID (result) is missing, being displayed twice or pending in the order list. d. No alarm or error occurred. If all four tests (ad) have passed, the analyzer is in working condition. Otherwise, the analyzer should not be used and Roche Technical Support should be contacted for tube detection sensor adjustments (CEAC - 08007720295). If you wish to notify technical complaints and adverse events use the following channels: Notivisa: Notices of adverse events (AE) and technical complaints (QT) for products subject to Sanitary Surveillance should be made through the NOTIVISA System. To access the System, you must register and select the Health Professional option, if you are a liberal professional or the Institution / Entity option, if you are a professional of an institution / entity. Technovigilance System: Patient or citizen can notify through the Technovigilance System / SISTEC access through the link