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.
데이터 추가 비고
원인
It has been determined that the pipettor may fail in very few cases (less than 1%) to dispense a urine sample due to a sample ''wicking'' where the dispensed sample remains adhered to the side of the pipette tip rather than dropping to the agar surface. in such cases the first plate may have no sample dispensed and a double volume may be dispensed on the next plate if a multiple plate panel is being used.