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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Immucor was notified by biotek instruments inc. that the power supply that was part of a galileo instrument being tested for compliance with present standards for immunity and emission failed the radiated emissions test (en 55011:2007 + a2: 2007).