Alerta De Seguridad para VANG VITROS REAGENT KIT Technical Name: VANCOMICINE ANVISA Registration Number: 80145900812 Hazard Class: II Affected Model: Box with 6 kits (Reagent 1: 9.7ml / Reagent 2: 4.9ml) Lot / Serial Numbers affected: SKU 6801709, lot 315506

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.

• Immediately discontinue use and dispose of all remaining inventory of VITROS VANC Reagent Packs for the affected lots listed above. NOTE: If you do not have an alternate lot in your inventory, refer to the information provided on page three for instructions on using your current lot until the replacement products arrive. • Complete and return the Receipt Confirmation. • Place this notification next to each VITROS System that uses the VITROS VANC Reagent Packs products or together with your user documentation