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 confirmed that a negative shift in quality control and patient sample recovery may be observed at the low end of the measuring range resulting in an increase in negative results with g flags when certain device lot numbers are used. additionally a blue precipitate has been observed in some reagent vials of these lots.