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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Results from a patient control sample could be misidentified by being associated with a pending test order for a patient sample already on the worklist when the following sequence of events occurs: - the primary identifier is tube position id - a patient control file is setup for id xxxxx and a pending test order for a patient sample id xxxxx is subsequently added to the worklist - the patient control sample is analyzed using cassette presentation but that tube does not contain a barcode-labeled speciment id or the label cannot be read.