Alerta De Seguridad para Chemistry Calibrator, 12 vials X 3 mL, Registration No. 10345160486, lot: 090445B, 090445C

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.

According to the company's manifestation, the slight positive change in direct bilirubin is observed in values ​​approximately ten times greater than the reference limit. In cases of hyperbilirubinemia due to hepatic obstruction, the change will have no impact on the use of the assay for diagnostic support. For instances of hyperbilirubinemia, which test is used to estimate indirect bilirubin in conjunction with total bilirubin, total bilirubin will be slightly underestimated. However, the clinical interpretation of the results will not be affected. For patients with elevated bilirubin overestimation will not impact treatment, since the values ​​will still support both diagnosis and prognosis. For determination of total bilirubin, a proportional decrease in indirect bilirubin will have no impact on the most vulnerable population - newborns due to immaturation of the glucuronidation pathway, so most circulating bilirubin will still be the indirect one.