Safety Alert for Trade name: Advia Chemistry Calibrator Technical name: CALIBRATORS AND MULTI-PARAMETER STANDARDS OF ONE OR MORE CONCENTRATIONS - CLASS II ANVISA Registration Number: 10345160486 Hazard Class: II Model Affected: Serial numbers affected: 680726; 680726A; 680726B; 680726C; 680726D

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 should use the new redefined values ​​for DBIL_2 ACVs from Chemistry Calibrator for batches 680726, 680726A, 680726B, 680726C, and 680726D provided on the notification letter. . To correct this bias, the value assigned to the DBIL_2 caliper must be reset to the specified batches. From lot 807936 of the Chemistry Calibrator, Siemens restored alignment with the reference method. Therefore, the reset of DBIL_2 is not required for this batch of Chemistry Calibrator. Patient results and Quality Controls will change proportionally to conform to the reference methodology, beginning with the redefinition of the calibrator value of lots 680726, 680726A, 680726B, 680726C and 680726D. The values ​​and ranges of the controls should be revised and adjusted accordingly.