25 VITRO CALIBRATOR KIT Technical Name: HIGH DENSITY LIPOPROTEIN ANVISA Registration Number: 80145900872 Hazard Class: II Model Affected: 25 VITER CALIBRATOR KIT Affected Series Numbers: VITROS Chemistry Products Calibrator Kit 25 - Code Product # 6801896 - Lot 2576 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.

• Inspect the bar code labels provided in the 25 VITROS Calibrator Kit, Lot 2576. • Dispose of the affected labels and manually program Batch 2576 by calibrating the VITROS dHDL Dry Reagents if the bar code labels indicate Lot 2575 instead of Lot 2576. • Complete the Receipt Confirmation form to record receipt of the notification.