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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We received one us customer complaint related to negative control out of range for zymutest hia iggam rk040d lot f1700415. subsequent investigation of this lot produced 2 false positive results. zymutest hia monostrip iggam rk041d lot 1700416 is also impacted as some components are common to both lots. use of these lots may produce false positive results.