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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A design error introduced in the field programmable gate array (fpga) was discovered. this fpga is a logic circuit on a chip embedded on the printed computer board (pcb) in the main unit of the xt-series analyzers. the error can present as an increase in the platelet (plt) count of up to double the correct count and/or the generation of excessive plt sampling errors. the increase in count and errors is caused by the circuit seeing a single platelet and creating two pulses that are included in the reported plt count.