Safety Alert for Trading name: Cobas 8000 Core Unit. Technical Name: Physiological Fluid Analyzer. ANVISA registration number: 10287410878. Class of risk: II. Model Affected: N / A. Serial numbers affected: 1137-08; 1149-06; 1150-01; 1162-10; 1163-02; 1211-02; 1211-03; 1212-10; 1216-19; 1220-17; 1221-07; 1287-10; 1290-02; 1296-09; 1339-03; 1339-04; 1365-01; 1365-02; 1365-09; 1374-06; 1374-10; 1476-04; 1476-05; 1478-08; 1480-09; 1480-10; 1481-07; 1482-03; 1485-06; 1486-02; 1492-03; 1492-04; 1492-05; 1495-09; 14A0-03; 14B8-07; 14B9-02; 14E2-06; 14E6-03; 14F1-13; 14F1-14; 14F1-20; 15G5-06; 15H3-02; 15H3-03; 15H3-04; 15H3-05; 15J5-09; 15J6-05; 15J6-07 ;. 15K4-08; 15K5-01; 15M4-01; 15M4-02; 15P0-01; 15P6-01; 15R9-07; 15R9-08; 15R9-10; 15S1-01; 15S3-02; 1618-07; 1618-08; 1628-02; 1640-06; 1653-03; 1656-06; 1657-02; 1657-03; 16S9-06; 16S9-07; 16U5-06; 16U5-07; 16U7-04; 16V8-04; 16V8-05; 16V8-06; 16V8-08; 16W0-10; 16X1-02; 16X1-03; 16X1-04; 16X1-05; 16Y7-01; 16Y7-02; 16Y7-03; 16Z1-09; 16Z7-08; 1776-05; 1776-07

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:> How to identify the error: There are two indicators that will identify if the described software problem occurred. Indicator 1: Check at least daily if the date is no longer displayed at the top of the User Interface screen (see Notification Figure 2). Whenever the date is not displayed at the top of the User Interface screen, software limitation has occurred on this instrument. Indicator 2: Whenever the Analytical Unit (AU) information is not visible in the Data Review screen (see Figure 3 below, with red marking), the software limitation has occurred in this instrument . > If the described software problem is present, stop the instrument by using the "Stop" button and contact Roche Diagnostica Brasil or your Authorized Representative to obtain the appropriate support for your system to be reconfigured . > Repeat the samples already evaluated after the problem has occurred (re-run the samples only after all the configurations have been set up again): It is recommended to re-measure the samples that were evaluated during the occurrence of the problem and until the instrument has been stopped . 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 - Date of identification of the problem by the company: 20/07/2017 - Date of notification notice to Anvisa: 08/18/2017 The company that owns the affected product is responsible for contacting its customers in a timely manner to ensure the effectiveness of the Field Action in progress. It stands out the joint responsibility of the distribution chain and use of health products in maintaining its quality, safety and efficacy, as well as the effectiveness of the Field Action, expressed by RDC 23/2012: "(...) Art 2 ° A holder of registration of health product is the holder of the registration / registration of health product with Anvisa. Single paragraph. The registration holder, as well as other agents involved from the production to the use of the product, or discarding it when applicable, are jointly and severally responsible for maintaining the quality, safety and efficacy of the health products to the final consumer. Art. 12 Distributors of health products shall forward to the registration holder, in a timely manner, the distribution map and other information requested for the notification and execution of field actions. (...) "