Alerta De Seguridad para ADVIA CENTAUR, Registration no. 10345160020 - Serial numbers - Attachment -Carta to the Client.

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.

The company informs that patient demographics (name, age, gender, ID) of an earlier sample are incorrectly transmitted to the LIS with the current patient sample results, the data also appears incorrectly in the worklist and printed reports . Patient outcomes are not affected if the ADVIA Centaur and ADVIA Centaur XP immunoassay systems use Sample ID (SID) as the primary identifier for all outcomes. A delay in reporting may occur. The overseas manufacturer performed the problem analysis, evaluating all the inherent risks that generated the corrective action in the field. Based on the investigation and mitigation of the risk conducted, this action was classified as without health risk, its severity being low and its probability of occurrence extremely unlikely.