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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Ocd received customer complaints for fetalscreen ii kit lot v116323 item z488 (exp: 10-jan-2012) pertaining to the positive control cell failing qc (less than 3 rosettes in 5 fields) or showing weakened reactivity. according to the alba bioscience product ifu if the total number of agglutinates or rosettes in 5 fields is 3 or more the test is positive.