Alerta De Seguridad para Trade name: ALDOLASE RANDOX. Technical Name: ALDOLASE. ANVISA registration number: 80158990141. Risk class: I - Low Risk. Model Affected: AD189. Batch / serial numbers affected: 370813; 365747; 347842; 347842; 339868; 339868; 330802; 322815

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.

Update the reagent installation with the correct settings using the data provided by the manufacturer. 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 Caution: This problem causes the customer who specifically uses the RX device to fail (RX4900 REGISTER no. 80158990104) unable to perform the calibration.