Safety Alert for ADVIA Centaur HCY (HOMOCYSTEIN) ANVISA Registry No. 10345160332.

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.

Upon receipt of the communication, the customer should discontinue the use of 1:10 dilutions of samples with the ADVIA Centaur Homocysteine ​​(HCY) assay run on the ADVIA Centaur, ADVIA Centaur XP and ADVIA Centaur CP systems. Ensure that 1:10 dilution will not be selected manually or automatically when performing a dilution. See the sections on Setting Automatic Dilution and Introduction to Dilution Options in the ADVIA Centaur System Operator's Guide. Customers can continue to use the 1: 2 dilution onboard or manual for samples with results outside the assay range. Siemens has confirmed that performance for this level of dilution meets the recovery described in the Instructions for Use.