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. Affected batch / serial numbers: SKU 6802156, lot 1570, 1580 의 안전성 경고

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 you are currently able to perform a successful calibration, implement the revisions on your VITROS System at your next scheduled calibration: o For VITROS® ECi / ECiQ Systems: Scan the Magnetic Batch Card for Batch 1580 or 1590. Discard / Original Magnetic Batch Card (green), supplied with the product. o For VITROS 3600, 5600 Systems: Install ADD DRV 5923 and later. Install the ADD 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 is available as of March 13, 2017. • If it is not possible to calibrate Batches 1580 or 1590, upon availability, use the new Magnetic Batch Card or ADD DRV 5923 for calibration. • If you have this problem and you no longer wish to use this product, Ortho will credit your account for the discarded product, or you will reimburse it for another product you have indicated. Resend the Receipt Confirmation form to indicate the amount that requires credit. • Place this notification next to each system that processes the VITROS Reagent Kits for NT-proBNP.