Safety Alert for Advia Centaur and Advia Centaur XP Immunoassay System. Anvisa Registries n ° 10345160020 and 10345160484.

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 Healthcare Diagnostics is conducting corrective field action for the ADVIA Centaur® and ADVIA Centaur® XP Immunoassay Systems for manual loading of sample racks that are improperly loaded or forced into the sample inlet queue during normal ADVIA Centaur and ADVIA Centaur XP Immunoassay Systems. Pushing the sample rack may cause sample read errors (SIDs) if the instructions for loading samples into the rack are not followed exactly as described in the ADVIA Centaur or AVDIA Centaur XP Operator's Guide. If the sample rack is manually driven by forcing too much of its input into the equipment without positioning it in the rack positioning guide, the pipe identification bar code can be assigned to different positions in the rack. This may lead to the wrong release of results. #### UPDATED ON 08/21/2017, the field action documentations submitted by the company are filed in the area. If necessary, the area can reassess the action at any time.