Safety Alert for ADVIA Centaur BR Technical Name: ANTIGEN CA ANVISA Registration Number: 10345161849 Hazard Class: III Affected Model: 250 Test Kit / 50 Test Kit

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.

Siemens advises customers who own multiple ADVIA Centaur, ADVIA Centaur XP or ADVIA Centaur XPT systems in their laboratory to process the Syphilis ADVIA Centaur and BR ADVIA Centaur assays in separate systems to avoid potential interference. If you are processing the Syphilis ADVIA Centaur and BR ADVIA Centaur assays in the same ADVIA Centaur system, ADVIA Centaur XP, or ADVIA Centaur XPT, process the Daily Cleaning Procedure (DCP) between the two tests to mitigate the interference. For example, this may require testing all BR samples in a non-random assay format, following the Daily Cleaning Procedure (DCP), and prior to performing any Syphilis tests. The company does not recommend a review of previously generated results.