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 potential that fluorescent platelet (plt-f) and immature platelet fraction (ipf%) results performed using affected lots of fluorocell plt may exhibit lower than expected plt-f and ipf values on the xn-series analyzers. the issue may be recognized by a large discrepancy between the impedance platelet (plt-i) value and a false low plt-f value. in most cases the falsely decreased plt-f results displayed a "plt abn scattergram" message with asterisks beside the results indicating the data is unreliable. in rare instances platelet flags may be absent. the plt-i counts are unaffected. this instance is a recurrence of a previously reported issue under incident 132547 on july 2016.