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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Sysmex america inc. has been made aware of a software defect on versions 6.0.1 and 6.0.2 running on the cellavision dm-series and sysmex di-60 that may cause comments to not be transmitted to the laboratory information system (lis). if all the following three conditions are met the comments will not be transmitted from the cellavision software to the lis: 1. the analyzer system computer server and remote review software installed is on version 6.0.1 or 6.0.2 and 2. the workflow with multiple slides for blood samples is used and 3. wbc rbc and plt comments are added to the last slide after it has been already signed.