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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Beckman coulter has reported intermittent suppressed patient results and an increased incidence of ind flags associated with the progesterone reagent pack lots identified. suppressed patient results have also been noted with the access cortisol reagent pack lot identified.