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
As an expansion to recall id 79537 ocd has recalled 3 lots of mts anti-igg card (mts084024) based on customer complaints of incomplete foil seals on the gel cards. although internal investigation demonstrated acceptable peel strength for the 3 affected lots and no complaints of erroneous results have been reported due to this issue ocd would like to remind users to inspect their gel cards upon receipt (as instructed by the product labeling).