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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Customers have observed that the differential results for coulter 5c abnormal ii cell control recovered an excessive number of incomplete computation (.....) and/or review ("r") flags on teh coulter lh 500 series and hmx analyzers. the issue may occur more often when laboratory temperatures fall below 70 degrees farenheit (21 degrees celsius).