Canadian data is current through March 2018. All of the data comes from Health Canada, 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 recall data from the U.S. and Canada.
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Beckman coulter inc. identified the following issue with the above listed product: 1.Access papp-a may exhibit increased imprecision for samples tested from the first two replicates of a reagent pack as compared to the remaining replicates. 2.This issue is only observed on the access platform including access 2 synchron lxi 725 and unicel dxc 600i. 3.Unicel dxi platforms are not impacted including unicel dxi 600 unicel dxi 800 unicel dxc 880i unicel dxc 860i unicel dxc 680i and unicel dxc 660i.