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
Iris diagnostics has become aware of a strip manufacturing error where an incorrect pad was inadvertently placed in the location of the leukocytes pad. all other analytes are correct. this defect exists on a subset of vials belonging to lot 7212154 a with the impacted vial numbers ranging from 01520 through 02401.