Alerte De Sécurité sur MULTIPARAMETER CONTROL OF PROTEINS - 1 x 1 ml; 1 x 2 ml; 1 x 5 ml; 2 x 1 ml - Registration 80115310078 - Affected lots: kit 1077281217 / bottle 1077261219.

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 Diagnostics NV, which manufactures high immunological control, routinely checks its standards and controls in use to assess the specificity, reliability, and traceability of its products. As a result of this process, APTEC reported a new reference value for the high immunological control present in batch PC 2017. Kovalent do Brasil Ltda receives this product as raw material from APTEC Diagnostics NV for the commercialization of the Kovalent Multiparametric Protein Control. The batch PC2017 of the APTEC control was used by Kovalent to generate the lot number kit 1077281217 / bottle 1077261219, thus, the Kovalent product will also have to change concentration value for Antithrombin III. Although the APTEC release also contains information on new reference values ​​for Alpha 1 glycoprotein (AGP), Immunoglobulin G (IgG) and Immunoglobulin M (IgM), it will not be necessary to communicate these parameters to our customers since Kovalent has already received the raw material with the correct values ​​for the AGP, IgG and IgM parameters. Thus, the kits were fabricated with the current values ​​for these parameters. Aptec's routine investigation, supplier of the raw material to Kovalent, revealed that target values ​​for multiparameter protein control 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. The product PROTEIN MULTIPARAMETER CONTROL is a control used to validate and check the conditions of an analytical system as well as to validate the calibration curve of each test. Therefore, poor control results should be identified by the users and each laboratory should establish corrective actions in cases of deviation in the recovery of controls, the results should be reviewed and the impact on the patients should be evaluated. There is no impact on the outcome of patients because the control presents different reference values, which are close, between the mono and bireagent presentations of the AGP, IgG and IgM tests. Anvisa follows this action. #### UPDATE: 09/14/2012 - The company forwards the file 0750021 / 12-1, where it declares the completion of the field action.