Technical Name: PARAMETERS COMBINED ON THE SAME PRODUCT - CLASS II ANVISA Registration Number: 10345160165 Hazard Class: II Affected Model: Commercial presentations of 2 vials of high calibrator and low calibrator (Calibrator A) Advia Centaur, ACS: 180 Systems 5.0mL / unit) and 6 bottles of high calibrator and low calibrator (5.0mL / unit). Serial numbers affected: 07996A90; 21172A90; 27221A90; 43871A90; 44366A90 의 안전성 경고

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.

Customers using the FT4 assay on the ADVIA Centaur, ADVIA Centaur XP & ADVIA Centaur XPT systems should discontinue use of the field affected lots for the FT4 assay. For the performance of this test, batch calibrators of numbering greater than the affected lot should be used. Customers can continue to use the affected Calibrator A batches for the Free T3 (FT3), Total T3 (T3), Total T4 (T4) and T uptake (Tup) assays for the ADVIA Centaur systems. Customers using the FT4 assay on the ADVIA Centaur CP system can continue to use all available Calibrator A batches. ### UPDATED ON 10/26/2017, the company presented the completion report of the field action proving the sending of the security warning to the client with evidence of science and all actions completed.