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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As a result of complaints received from the field the manufacturer biokit s.A. has initiated a recall of this kit and lot numbers kj06021 and kj11034. the complaints were related to weak or negative reactions with s. aureus cultures. investigations have been conducted to determine the root cause of the problem.