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
Software error that results in the failure of the concentrated wash solution pump to stop creating an overflow or leak on each analyzer unit. the leak would be visually apparent and an on-screen and audible alarm "3639 master detergent overflow [unit #]" is generated alerting the operator of an instrument problem.