Safety Alert for Trading name: Cobas e801 Module. Technical name: Instrument for immunoassays. ANVISA registration number: 10287411196. Class of risk: II. Model affected: -. Lots / series numbers affected :. 1741-08 (Roche), 1765-02, 1766-04, 1766-05, 1768-07, 1768-08, 1768-09, 1767-08, 1768-10, 1767-07, 1772-04, 1771-03 , 1771-06, 1787-10, 1788-01, 1791-06, 1791-07, 1796-09, 1796-10, 1797-04, 1799-04, 1799-05, 18E0-04 (Roche) and 18E0- 05 (Roche)

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.

A new hardware modification kit that solves this problem was developed by the manufacturer and is being imported by Roche Diagnóstica Brasil to be made available to customers as soon as possible. If you are unable to apply the final solution mentioned above (change kit installation) in a timely manner, temporarily follow one of the options listed below (workarounds):> Option 1 (workaround): Use only those tests that do not require prewash stages and tests that are not impacted by the lack of prewash steps. The lists can be found in "Important Information" in Table 1 and Table 2. Important: The tests listed in Table 3 in "Important Information" should NOT be measured until the installation of the modification kit has been completed. These tests should be masked by following the cobas® 8000 Operator's Manual> Option 2 (workaround): The workaround (option 2) requires an intervention from a Roche representative for the required configuration of the data manager: the consequences on the workflow needs to be considered. Visually inspect the prewash syringe plunger functionality (PreWash) before manually releasing the results to the Host / LIS, until the final solution is implemented. The automatic data transfer function of the patient sample results in the data manager needs to be disabled, so the patient results measured in the cobas and 801 module (only pre-wash tests) will not be automatically transferred to the Host / LIS. Instead, these results must be manually released to the Host / LIS upon visual verification of the functionality of the prewash syringe plunger (PW). Follow the procedure described in the notification letter and its corresponding attachment. 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 Additional information: - Date of identification of the problem by the company: 02/28/2018 - Date of notification notice for Anvisa: 05/04/2018 The company that owns the affected product is responsible for contacting its customers in due time. 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. (...) "