Safety Alert for Trade name: Chemical Efficiency Checker And Ii Vitros *. Technical Name: Combined Parameters In Same Product - Class II. ANVISA registration number: 10132590232. Class of risk: II. Affected model: 12 x 3 ml of the level I lyophilized checker; 12 x 5 ml diluent for level II verifier; 12 x 3 ml of the level II lyophilized checker; 12 x 5 ml diluent for Level I verifier. Serial numbers affected: SKU: 8231474 | Lot: K4852

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.

Be aware that closed bottles of Batch K4852 can no longer be stored refrigerated to check the performance of VITROS AST or ASTJ Slides. Discard any remaining stock refrigerated stored if used to check VITROS AST or ASTJ Slides. Keep this notification as a verification of the revised instructions. 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