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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Iris international has determined that the iq200 series urine microscopy analyzer with barcode reader (model nft-2100) may intermittently exhibit the following: - failure to read the urine sample dilution barcode label where it defaults to a dilution factor of 1:1 and does not apply the correct dilution factor. - failure to read body fluid dilution barcode label where the rack is rejected and no results are generated.