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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There is a low frequency defect in the molding of the cuvettes that may result in cuvette ring and cuvette loader jams. jams will cause downtime on the system. the molding defect can result in the cuvette flange or "wing" breaking resulting in an error condition. no results are reported when jams occur therefore patiet results are not impacted.