Alerta De Seguridad para REAGENT KIT hsCRP VITROS, Model HsCRP Reagent Kit Cx 6 / 50T - Registro 80145900837 - Lote 28-3487

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.

The company informs that European Reference Material (ERM) is a calibration reference standard used to support the assigned value of the calibrator kit VITROS® 17 and VITROS® FS Calibrator 1. Both calibrators are used together to calibrate the calibration systems. VITROS® 5,1 FS, VITROS®4600 and VITROS®5600 integrated systems for quantitative measurement of Reactive Protein C (CRP) using the VITROS hsCRP reagent. CRP is used to assess the risk of developing coronary heart disease (CHD). The risk of coronary heart disease increases with CRP values ​​greater than 3 mg / L. The client should discuss any concerns they may have about the results reported previously with their medical director or the requesting physician. The results from this or any other diagnostic test should be used and interpreted only in the context of the entire clinical picture #### UPDATED ON 08/18/2017, the field action documentations submitted by the company are filed in the area. If necessary, the area can reassess the field action at any time.