Alerta De Seguridad para VITROS NT-PRO BNP REAGENT KIT Technical Name: HUMAN BRAIN NATURAL URBRID PEPTIDE (BNP) ANVISA Registration Number: 80145900933 Hazard Class: II Affected Model: Kit consisting of: 100 coated wells; 8.2 ml of conjugated reagent; 8.2 ml of biotinylated antibody reagent. Serial numbers affected: SKU: 6802156 | Lot: 1620

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.

If a successful calibration is currently possible, implement the revisions in your system: o For VITROS® ECi / ECiQ Systems: At your next scheduled calibration, scan the Yellow Magnetic Batch Card from Lot 1620. Discard / Destroy Lot Card Magnetic original (green), supplied with the product. o For VITROS 3600, 5600 Systems: Install ADD DRV 5932 and later using the "Full Load" (All Assay Data) option. After loading the ADD for the first time, the VITROS Reagent Kits for NT-proBNP will lose the calibration and must be recalibrated. After successful calibration and quality control evaluation, it is acceptable to use your remaining inventory. NOTE: For e-Connected systems, download will be available around Saturday, May 13, 2017. • If Lot 1620 can not be calibrated, upon availability, use the new Magnetic Batch Card or ADD DRV 5932 to calibrate. • If you have this problem and no longer wish to use this product, Ortho will credit your account for the discarded product. • Place this notification next to each system that processes the VITROS Reagent Kits for NT-proBNP.