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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The clinitek atlas positive control and chek-stix positive control for leukocyte reconstituted fails to meet ifu claims. when these lots (mentioned above) of control material are reconstituted the positive control solution leukocyte result may become negative if the solution is held for more than two hours above 25 c (77 f).