Safety Alert for ADVIA CHEMISTRY LIPASE REAGENTS (LIP) - Record 10345160626 - Model Kit of 4 x 160 tests: Reagent 1 (4 x 18 ml) / Reagent 2 (4 x 10 ml) - Lots 332463; 318706 (SCHEDULE OF DISTRIBUTION IN ANNEX)

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.

Company recommends: "* If the lipid panel (Triglycerides, Triglycerides, Triglycerides Concentrate, Cholesterol Concentrate and LDL Direct Cholesterol) is not being used together with the determination of Lipase in ADVIA Chemistry Systems, no action is required. * If the lipid panel is used in conjunction with Lipase in the ADVIA Chemistry Systems, Siemens recommends the following protocol to minimize the potential for falsely elevated Lipase assay results. a) Customers with two or more ADVIA Chemistry Systems shall perform the defined tests on the Lipid and Lipase panel in ADVIA Chemistry Systems separately. b) Clients with a single ADVIA Chemistry System and laboratories that choose to maintain lipase in the same system with the lipid panel should perform the automatic replication protocol described in the Letter to Customer to mitigate the possibility of obtaining falsely elevated Lipase test results. ".