Alerta De Seguridad para MULTIPARAMETER STANDARDS CONTROL - CONTROL AND MULTIPARAMETER STANDARDS FOR SERIES PROTEINS - 5 x 1 ml MULTIPARAMETER STANDARDS // 1 X 5 ml MULTIPARAMETER CONTROL - Registration 10350840039 - Lots Affected: 318 / PC2017 and 319 / PC2017.

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.

APTEC's quality control department routinely checks its standards and controls in use to assess specificity, reliability, and traceability. As a result of this process, APTEC reported new reference values ​​for high immunological control (GIFTS IN THE LOTS 318 / PC2017 AND 319 / PC2017 OF THE MULTIPROTEIN STANDARD CONTROL PRODUCT) for AGP, IgG, IgM and Antithrombin III parameters. Routine investigation of the Aptec with the analyte revealed that the target values ​​for the immunological control of proteins were different depending on whether the reagent used was mono or bireagent. The use of different values ​​for mono or bireagent presentations provides greater accuracy, confidence and specificity to the Alpha 1-Glycoprotein result. Anvisa is following this action. #### UPDATE: 09/14/2012 - The company forwards file 0750234 / 12-6, where it declares the completion of the field action.