Safety Alert for Trade name: ADVIA Centaur Cyclosporin (CsA); ADVIA Centaur DHEA-SO4 (DHEAS); ADVIA CENTAUR FOL; ADVIA CENTAUR HBc IgM-. Technical Name: Ciclosporin; Dehydroepiandrosterone Sulfate (Dhea-S); Folate. Nuclear Immunoglobulin M for Hepatitis B Virus. ANVISA registration number: 10345161772; 10345161738; 10345160571; 10345160594. Class of risk: III; II; II; IV. Model Affected: N / A. Serial number affected: See distribution map

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.

The probability of misinterpretation of the results for the above tests due to this problem is remote. Mitigations include correlation with clinical history and presentation of other laboratory diagnostic tests and / or serial tests, depending on the analyte. Siemens does not recommend a review of past results because of this problem. Users and customers should consult the information provided in the Notification Letter until the updates to the instructions for use (IFU) regarding biotin interference are completed. 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 http://www.anvisa.gov.br/sistec/alerta/RelatorioAlerta.asp?ComeName=CO_SEQ_ALERTA&Parametro;;; Additional information: - Date of identification of the problem by the company: 02/01/2018 - Date of entry of the notification to the Anvisa: 02/01/2018 The company holding the record of the affected product is responsible for timely contacting its clients in order to guarantee the effectiveness of the Field Action in progress.