Alerta De Seguridad para Commercial Name: Architect Dhea-S Reagent Kit / Architect Dhea-S Reagent Kit. Technical Name: Dehydroepiandrosterone Sulfate (DHEA-S). ANVISA registration number: 80146501346. Class of risk: II. Affected Model: Not applicable. Serial Numbers Affected: 01316K000; 01217A000; 02217D000; 04117H000; 01216K000; 01117A000; 02217C000; 02317D000; 02417D000; 00517F000

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.

1) Immediately discontinue use of the ARCHITECT DHEA-S assay with samples of children up to 60 days of age. 2) Immediately discontinue the use of representative data from the Expected Values ​​section of the ARCHITECT DHEA-S reagent instructions for children up to 10 years of age. 3) Review this statement with your medical director and follow your laboratory protocol regarding the need to review patient outcomes already reported. 4) If you have forwarded the product listed above to other laboratories, please inform them of this Product Fix and provide a copy of this notice. 5) Please complete and submit the Customer Response Form. 6) Keep this statement in your lab files. 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: 12/14/2017 - Date of notification notice to Anvisa: 11/01/2018 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. (...) "